PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves
Device Facts
| Record ID | K262014 |
|---|---|
| Device Name | PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves |
| Applicant | O&M Halyard, Inc. |
| Product Code | LZA · General Hospital |
| Decision Date | Jul 21, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Indications for Use
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs, Fentanyl Citrate, and a 50/50 mixture of Fentanyl Citrate and Simulated Gastric Fluid using ASTM D6978-05.
Device Story
Disposable, blue, ambidextrous, non-sterile nitrile examination gloves with beaded cuffs; intended for medical examination to prevent cross-contamination. Used in clinical settings by healthcare providers. Tested for permeation resistance against chemotherapy drugs, Fentanyl Citrate, and simulated gastric fluid per ASTM D6978-05. Output is a physical barrier; informs clinical decision-making regarding protection during handling of hazardous drugs. Benefits include reduced exposure risk to patient and examiner.
Clinical Evidence
No clinical data. Bench testing only, including physical dimensions, tensile strength, elongation, water leak (ASTM D5151), powder residue (ASTM D6124), chemotherapy permeation (ASTM D6978-05), and biocompatibility (ISO 10993-10/11).
Technological Characteristics
Nitrile material; powder-free; blue; beaded cuff; ambidextrous. Dimensions: 240mm (MARIN) or 295mm (MARIN-XTRA) length; 0.1mm finger/0.08mm palm thickness. Tensile strength >= 14MPa; elongation >= 500% (before aging). Tested per ASTM D6319, D5151, D6124, D6978, D7160. Biocompatibility per ISO 10993-10/11.
Indications for Use
Indicated for use as a disposable medical glove worn on the examiner's hand to prevent cross-contamination between patient and examiner. Tested for use with specific chemotherapy drugs, Fentanyl Citrate, and simulated gastric fluid. Not for use with Carmustine and Thiotepa.
Regulatory Classification
Identification
A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
Predicate Devices
- PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves (K220547)
Submission Summary (Full Text)
{0}
July 21, 2026
O&M Halyard, Inc.
Sahrudin Shah
Regulatory Affairs Specialist
1220 Old Alpharetta Rd.
Suite 320
Alpharetta, Georgia 30005
Re: K262014
Trade/Device Name: PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves
Regulation Number: 21 CFR 880.6250
Regulation Name: Non-Powdered Patient Examination Glove
Regulatory Class: Class I, reserved
Product Code: LZA, LZC, OPJ, QDO
Dated: June 15, 2026
Received: June 15, 2026
Dear Sahrudin Shah:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K262014 - Sahrudin Shah
Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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K262014 - Sahrudin Shah
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
ALLAN GUAN -S
For Bifeng Qian, M.D., Ph.D.
Assistant Director
DHT4C: Division of Infection Control Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
# Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K262014
Device Name
PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves
PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves
Indications for Use (Describe)
PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves - Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid Fluid.
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs, Fentanyl Citrate, and a 50/50 mixture of Fentanyl Citrate and Simulated Gastric Fluid using ASTM D6978-05.
The following chemicals (chemotherapy and non-chemotherapy drugs) have been tested with these gloves:
| Chemotherapy Drugs | Concentration mg/mL | Breakthrough Detection Time in Minutes |
| --- | --- | --- |
| 1 Cisplatin, | 1mg/mL (1,000 ppm) | >240min |
| 2 Cyclophosphamide (Cytoxan) | 20mg/mL (20,000 ppm) | >240min |
| 3 Dacarbazine (DTIC) | 10mg/mL (10,000 ppm) | >240min |
| 4 Doxorubicin HCl (Adriamycin) | 2mg/mL (2,000 ppm) | >240min |
| 5 Etoposide (Toposar) | 20mg/mL (20,000 ppm) | >240min |
| 6 Fluorouracil (5 Flu) | 50mg/mL (50,000 ppm) | >240min |
| 7 Ifosfamide (IFEX) | 50mg/mL (50,000 ppm) | >240min |
| 8 Methotrexate | 25mg/mL (25,000 ppm) | >240min |
| 9 Mitomycin C | 0.5 mg/mL (500 ppm) | >240min |
| 10 Mitoxantrone HCl | 2mg/mL (2,000 ppm) | >240min |
| 11 Paclitaxel (Taxol) | 6mg/mL (6,000 ppm) | >240min |
| 12 Vincristine Sulphate | 1mg/mL (1,000 ppm ) | >240 min |
| 13 Carmustine | 3.3mg/mL (3,300 ppm) | 40 min |
| 14 Thiotepa | 10mg/mL (10,000 ppm) | 88.6 min |
| Non-chemotherapy Drugs | Concentration mg/mL | Breakthrough Detection Time in Minutes |
| 1 Fentanyl Citrate Injection | 100mcg/2mL | >240min |
| 2 Simulated Gastric Acid Fluid / Fentanyl Citrate Injection Mix 50/50 Solution | 50% (v/v) mixture | >240min |
The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes:
Carmustine 3.3mg/mL (3,300 ppm), breakthrough detected at 40 minutes
Thiotepa 10mg/mL (10,000 ppm), breakthrough detected at 88.6 minutes
Warning: Not for use with Carmustine and Thiotepa
FORM FDA 3881 (8/23)
Page 1 of 2
PSC Publishing Services (301) 443-6740
EF
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# PUREZERO® MARIN-XTRA® Nitrile Powder-Free Exam Gloves
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs, Fentanyl Citrate, and a 50/50 mixture of Fentanyl Citrate and Simulated Gastric Fluid using ASTM D6978-05.
The following chemicals (chemotherapy and non-chemotherapy drugs) have been tested with these gloves:
| Chemotherapy Drugs | Concentration mg/mL | Breakthrough Detection Time in Minutes |
| --- | --- | --- |
| 1 Cisplatin, | 1mg/mL (1,000 ppm) | >240min |
| 2 Cyclophosphamide (Cytoxan) | 20mg/mL (20,000 ppm) | >240min |
| 3 Dacarbazine (DTIC) | 10mg/mL (10,000 ppm) | >240min |
| 4 Doxorubicin HCl (Adriamycin) | 2mg/mL (2,000 ppm) | >240min |
| 5 Etoposide (Toposar) | 20mg/mL (20,000 ppm) | >240min |
| 6 Fluorouracil (5 Flu) | 50mg/mL (50,000 ppm) | >240min |
| 7 Ifosfamide (IFEX) | 50mg/mL (50,000 ppm) | >240min |
| 8 Methotrexate | 25mg/mL (25,000 ppm) | >240min |
| 9 Mitomycin C | 0.5 mg/mL (500 ppm) | >240min |
| 10 Mitoxantrone HCl | 2mg/mL (2,000 ppm) | >240min |
| 11 Paclitaxel (Taxol) | 6mg/mL (6,000 ppm) | >240min |
| 12 Vincristine Sulphate | 1mg/mL (1,000 ppm ) | >240 min |
| 13 Carmustine | 3.3mg/mL (3,300 ppm) | 40 min |
| 14 Thiotepa | 10mg/mL (10,000 ppm) | 88.6 min |
| Non-chemotherapy Drugs | Concentration mg/mL | Breakthrough Detection Time in Minutes |
| 1 Fentanyl Citrate Injection | 100mcg/2mL | >240min |
| 2 Simulated Gastric Acid Fluid / Fentanyl Citrate Injection Mix 50/50 Solution | 50% (v/v) mixture | >240min |
The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes:
Carmustine 3.3mg/mL (3,300 ppm), breakthrough detected at 40 minutes
Thiotepa 10mg/mL (10,000 ppm), breakthrough detected at 88.6 minutes
Warning: Not for use with Carmustine and Thiotepa
Type of Use (Select one or both, as applicable)
☐
Prescription Use (Part 21 CFR 801 Subpart D)
☑
Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (8/23)
Page 2 of 2
PSC Publishing Services (301) 443-6740
EF
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510(k) Summary
The assigned 510(k) Number: K262014
## 510(k) Summary
1. Date of Submission: 15th June 2026
2. Sponsor Identification:
O&M Halyard, Inc.
1220 Old Alpharetta Road,
Ste. 320, Alpharetta GA 30005 United States
3. Designated Submission Correspondent: Mr. Sahrudin Shah, Regulatory Affairs Specialist
4. Identification of Proposed Device:
PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves
PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves
Regulatory Information
Classification Name: Non-Powdered Patient Examination Glove
Classification: I
Page | 1 of 10
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510(k) Summary
Product Code: LZA, LZC, QDO, OPJ
Regulation Number: 880.6250
Regulation Name: Non-powdered patient examination glove
Review Panel: General Hospital
5. Identification of Predicate Device(s)
510(k) Number: K220547
6. Device Description:
PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves and PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves are disposable, blue-colored, ambidextrous, non-sterile nitrile examination gloves with beaded cuffs. These gloves have been tested for use with Chemotherapy drugs, Fentanyl Citrate, and a 50/50 mixture of Fentanyl Citrate and Simulated Gastric Fluid.
Page | 2 of 10
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510(k) Summary
# 7. Indication For Use Statement:
# **PUREZERO\* MARIN\* Nitrile Powder-Free Exam Gloves**
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs, Fentanyl Citrate, and a 50/50 mixture of Fentanyl Citrate and Simulated Gastric Fluid using ASTM D6978-05. The following chemicals (chemotherapy and non-chemotherapy drugs) have been tested with these gloves:
| No. | Chemotherapy Drugs | Breakthrough Detection Time in Minutes |
| --- | --- | --- |
| 1 | Cisplatin, 1mg/mL (1,000 ppm) | > 240min |
| 2 | Cyclophosphamide (Cytoxan), 20mg/mL (20,000 ppm) | > 240min |
| 3 | Dacarbazine (DTIC), 10mg/mL (10,000 ppm) | > 240min |
| 4 | Doxorubicin HCl (Adriamycin), 2mg/mL (2,000 ppm) | > 240min |
| 5 | Etoposide (Toposar), 20mg/mL (20,000 ppm) | > 240min |
| 6 | Fluorouracil (5 Flu), 50mg/mL (50,000 ppm) | > 240min |
| 7 | Ifosfamide (IFEX), 50mg/mL (50,000 ppm) | > 240min |
| 8 | Methotrexate, 25mg/mL (25,000 ppm) | > 240min |
| 9 | Mitomycin C, 0.5 mg/mL (500 ppm) | > 240min |
| 10 | Mitoxantrone HCl, 2mg/mL (2,000 ppm) | > 240min |
| 11 | Paclitaxel (Taxol), 6mg/mL (6,000 ppm) | > 240min |
| 12 | Vincristine Sulphate, 1mg/mL (1,000 ppm ) | > 240 min |
| 13 | Carmustine, 3.3mg/mL (3,300 ppm) | 40 min |
| 14 | Thiotepa, 10mg/mL (10,000 ppm) | 88.6 min |
| No. | Non-chemotherapy Drugs | Breakthrough Detection Time in Minutes |
| 1 | Fentanyl Citrate Injection, 100mcg/2mL | > 240min |
| 2 | Simulated Gastric Acid Fluid / Fentanyl Citrate Injection Mix 50/50 Solution | > 240min |
The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes:
Carmustine 3.3mg/mL (3,300 ppm), breakthrough detected at 40 minutes
Thiotepa 10mg/mL (10,000 ppm), breakthrough detected at 88.6 minutes
Warning: Not for use with Carmustine and Thiotepa
# **PUREZERO\* MARIN-XTRA\* Nitrile Powder-Free Exam Gloves**
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs, Fentanyl Citrate, and a 50/50 mixture of Fentanyl Citrate and Simulated Gastric Fluid using ASTM D6978-05. The following chemicals (chemotherapy and non-chemotherapy drugs) have been tested with these gloves:
| No. | Chemotherapy Drugs | Breakthrough Detection Time in Minutes |
| --- | --- | --- |
| 1 | Cisplatin, 1mg/mL (1,000 ppm) | > 240min |
| 2 | Cyclophosphamide (Cytoxan), 20mg/mL (20,000 ppm) | > 240min |
| 3 | Dacarbazine (DTIC), 10mg/mL (10,000 ppm) | > 240min |
| 4 | Doxorubicin HCl (Adriamycin), 2mg/mL (2,000 ppm) | > 240min |
| 5 | Etoposide (Toposar), 20mg/mL (20,000 ppm) | > 240min |
| 6 | Fluorouracil (5 Flu), 50mg/mL (50,000 ppm) | > 240min |
| 7 | Ifosfamide (IFEX), 50mg/mL (50,000 ppm) | > 240min |
| 8 | Methotrexate, 25mg/mL (25,000 ppm) | > 240min |
| 9 | Mitomycin C, 0.5 mg/mL (500 ppm) | > 240min |
| 10 | Mitoxantrone HCl, 2mg/mL (2,000 ppm) | > 240min |
| 11 | Paclitaxel (Taxol), 6mg/mL (6,000 ppm) | > 240min |
| 12 | Vincristine Sulphate, 1mg/mL (1,000 ppm ) | > 240 min |
| 13 | Carmustine, 3.3mg/mL (3,300 ppm) | 40 min |
| 14 | Thiotepa, 10mg/mL (10,000 ppm) | 88.6 min |
| No. | Non-chemotherapy Drugs | Breakthrough Detection Time in Minutes |
| 1 | Fentanyl Citrate Injection, 100mcg/2mL | > 240min |
| 2 | Simulated Gastric Acid Fluid / Fentanyl Citrate Injection Mix 50/50 Solution | > 240min |
The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes:
Carmustine 3.3mg/mL (3,300 ppm), breakthrough detected at 40 minutes
Thiotepa 10mg/mL (10,000 ppm), breakthrough detected at 88.6 minutes
Warning: Not for use with Carmustine and Thiotepa
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510(k) Summary
# 8. Substantially Equivalent (SE) Comparison
Table 1 General Comparison
| ITEM | Proposed Device (K262014) | | Predicate Device (K220547) | Remark |
| --- | --- | --- | --- | --- |
| Trade Name | PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves | PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves | PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves | SAME |
| Product Code | LZA, LZC, QDO, OPJ | | LZA, LZC, QDO, OPJ | SAME |
| Classification Regulation | 21 CFR 880.6250 | | 21 CFR 880.6250 | SAME |
| Class | I | | I | SAME |
| Indication for use | **PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves - Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid Fluid:** The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs, Fentanyl Citrate, and a 50/50 mixture of Fentanyl Citrate and Simulated Gastric Fluid using ASTM D6978-05. The following chemicals (chemotherapy and non-chemotherapy drugs) have been tested with these gloves: | **PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves - Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid Fluid.** The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs, Fentanyl Citrate, and a 50/50 mixture of Fentanyl Citrate and Simulated Gastric Fluid using ASTM D6978-05. The following chemicals (chemotherapy and non-chemotherapy drugs) have been tested with these gloves: | The PureZero MARIN Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim and PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. | Analysis 1 |
Page | 4
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510(k) Summary
| | No. | Chemotherapy Drugs | Breakthrough Detection Time in Minutes | No. | Chemotherapy Drugs | Breakthrough Detection Time in Minutes | The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:Coplatin (1 mg/ml)Cyclophosphamide (20 mg/ml)Decarbazine (10 mg/ml)Doxorubicin HCl (2 mg/ml)Etoposide (20 mg/ml)Fluorouracil (50 mg/ml)Ifosfamide (30 mg/ml)Methotrexate (25 mg/ml)Mitomycin C (0.3 mg/ml)Mitotaxime HCl (2 mg/ml)Paclitaxel (8 mg/ml)Vincristine Sulfate (1 mg/ml)Fentanyl Citrate Injection (100 mcg/2 mL)Sunnated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50:50 SolutionThe following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes:Carmustine (3.3 mg/ml), breakthrough detected at 55.2 minutesThiotepa (10 mg/ml), breakthrough detected at 88.6 minutesWarning: Not for use with Carmustine and Thiotepa. | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | 1 | Cisplatin, 1mg/ml, (1,000 ppm) | >240min | 1 | Cisplatin, 1mg/ml, (1,000 ppm) | >240min | | |
| 2 | Cyclophosphamide (Cytoran), 20mg/ml, (20,000 ppm) | >240min | 2 | Cyclophosphamide (Cytoran), 20mg/ml, (20,000 ppm) | >240min | Cisplatin (1 mg/ml)Cyclophosphamide (20 mg/ml)Decarbazine (10 mg/ml)Doxorubicin HCl (2 mg/ml)Etoposide (20 mg/ml)Fluorouracil (50 mg/ml)Ifosfamide (30 mg/ml)Methotrexate (25 mg/ml)Mitomycin C (0.3 mg/ml)Mitotaxime HCl (2 mg/ml)Paclitaxel (8 mg/ml)Vincristine Sulfate (1 mg/ml)Fentanyl Citrate Injection (100 mcg/2 mL)Sunnated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50:50 Solution | | |
| 3 | Doxorubicin (DTIC), 10mg/ml, (10,000 ppm) | >240min | 3 | Doxorubicin (DTIC), 10mg/ml, (10,000 ppm) | >240min | | | |
| 4 | Doxorubicin HCl (Adriamycin), 2mg/ml, (2,000 ppm) | >240min | 4 | Doxorubicin HCl (Adriamycin), 2mg/ml, (2,000 ppm) | >240min | | | |
| 5 | Etoposide (Topoxan), 20mg/ml, (20,000 ppm) | >240min | 5 | Etoposide (Topoxan), 20mg/ml, (20,000 ppm) | >240min | | | |
| 6 | Fluorouracil (5 Flot), 50mg/ml, (50,000 ppm) | >240min | 6 | Fluorouracil (5 Flot), 50mg/ml, (50,000 ppm) | >240min | | | |
| 7 | Ifosfamide (IFEX), 50mg/ml, (50,000 ppm) | >240min | 7 | Ifosfamide (IFEX), 50mg/ml, (50,000 ppm) | >240min | | | |
| 8 | Methotrexate, 25mg/ml, (25,000 ppm) | >240min | 8 | Methotrexate, 25mg/ml, (25,000 ppm) | >240min | | | |
| 9 | Mitomycin C, 0.5 mg/ml, (500 ppm) | >240min | 9 | Mitomycin C, 0.5 mg/ml, (500 ppm) | >240min | | | |
| 10 | Mitotaxime HCl, 2mg/ml, (2,000 ppm) | >240min | 10 | Mitotaxime HCl, 2mg/ml, (2,000 ppm) | >240min | | | |
| 11 | Paclitaxel (Taroft), 6mg/ml, (6,000 ppm) | >240min | 11 | Paclitaxel (Taroft), 6mg/ml, (6,000 ppm) | >240min | | | |
| 12 | Vincristine Sulphate, 1mg/ml, (1,000 ppm) | >240 min | 12 | Vincristine Sulphate, 1mg/ml, (1,000 ppm) | >240 min | | | |
| 13 | Carmustine, 3.3mg/ml, (3,300 ppm) | 40 min | 13 | Carmustine, 3.3mg/ml, (3,300 ppm) | 40 min | | | |
| 14 | Thiotepa, 10mg/ml, (10,000 ppm) | 88.6 min | 14 | Thiotepa, 10mg/ml, (10,000 ppm) | 88.6 min | | | |
| No. | Non-chemotherapy Drugs | Breakthrough Detection Time in Minutes | No. | Non-chemotherapy Drugs | Breakthrough Detection Time in Minutes | | | |
| 1 | Fentanyl Citrate Injection, 100mcg/2mL | >240min | 1 | Fentanyl Citrate Injection, 100mcg/2mL | >240min | | | |
| 2 | Sunnated Gastric Acid Fluid / Fentanyl Citrate Injection Mix 50:50 Solution | >240min | 2 | Sunnated Gastric Acid Fluid / Fentanyl Citrate Injection Mix 50:50 Solution | >240min | | | |
| The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes:Carmustine 3.3mg/mL (3,300 ppm), breakthrough detected at 40 minutesThiotepa 10mg/mL (10,000 ppm), breakthrough detected at 88.6 minutesWarning: Not for use with Carmustine and Thiotepa. | | | The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes:Carmustine 3.3mg/mL (3,300 ppm), breakthrough detected at 40 minutesThiotepa 10mg/mL (10,000 ppm), breakthrough detected at 88.6 minutesWarning: Not for use with Carmustine and Thiotepa | | | | | |
| Material | Nitrile | | Nitrile | | Nitrile | SAME | | |
| Powder or Powder Free | Powder Free | | Powder Free | | Powder Free | SAME | | |
| Color | Blue | | Blue | | Blue | SAME | | |
| Single use | Single use | | Single use | | Single use | SAME | | |
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510(k) Summary
| Biocompatibility | Acute Systemic Toxicity ISO 10993-11:2017 Skin Sensitization ISO 10993-10: 2010 Irritation ISO 10993-10: 2010 | Acute Systemic Toxicity ISO 10993-11:2017 Skin Sensitization ISO 10993-10: 2010 Irritation ISO 10993-10: 2010 | Acute Systemic Toxicity ISO10993-11:2017 Skin Sensitization ISO 10993-10: 2010 Irritation ISO 10993-10: 2010 | SAME |
| --- | --- | --- | --- | --- |
| Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid Claim | Refer to Table 3 | Refer to Table 3 | Refer to Table 3 | Analysis 1 |
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510(k) Summary
Table 2 Technological Characteristic Comparison
| Technological Characteristics | Proposed Device (K262014) | | Predicate Device (K220547) | SAME |
| --- | --- | --- | --- | --- |
| | PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves | PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves | PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves | |
| Physical Dimension: | | | | |
| Length | Minimum 240mm (9.5-inch) | Minimum 295mm (12-inch length) | Minimum 240 for MARIN Minimum 295mm for MARIN-XTRA | SAME |
| Palm Width (size) (mm): | | | | |
| XS | 60-80 | 60-80 | 60-80 | SAME |
| S | 70-90 | 70-90 | 70-90 | SAME |
| M | 85-105 | 85-105 | 85-105 | SAME |
| L | 100-120 | 100-120 | 100-120 | SAME |
| XL | 110-130 | 110-130 | 110-130 | SAME |
| Thickness (mm): | | | | |
| Finger | Minimum 0.1 | Minimum 0.1 | Minimum 0.1 | SAME |
| Palm | Minimum 0.08 | Minimum 0.08 | Minimum 0.08 | SAME |
| Tensile Strength, Before Aging | 14MPa, min | 14MPa, min | 14MPa, min | SAME |
| Ultimate Elongation, Before Aging | 500%, min | 500%, min | 500%, min | SAME |
| Tensile Strength, After Accelerated Aging | 14MPa, min | 14MPa, min | 14MPa, min | SAME |
| Ultimate Elongation, After Accelerated Aging | 400%, min | 400%, min | 400%, min | SAME |
| Watertight (1000ml) | 21 CFR 800.20 ASTM D5151 G-1, AQL 2.5 | 21 CFR 800.20 ASTM D5151 G-1, AQL 2.5 | 21 CFR 800.20 ASTM D5151 G-1, AQL 2.5 | SAME |
| Powder-Content | ≤ 2 mg per glove | ≤ 2 mg per glove | ≤ 2 mg per glove | SAME |
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510(k) Summary
Table 3 Chemotherapy Permeation and Fentanyl Citrate Comparison
| Tested Chemotherapy Drug, Fentanyl Citrate and Gastric Acid Fluid | Minimum BDT (Minutes) | | |
| --- | --- | --- | --- |
| | Proposed Device (K262014) | | Predicate Device (K220547) |
| | PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves | PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves | PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves |
| Cisplatin, 1mg/mL (1,000 ppm) | >240min | >240min | >240min |
| Cyclophosphamide (Cytoxan), 20mg/mL (20,000 ppm) | >240min | >240min | >240min |
| Dacarbazine (DTIC), 10mg/mL (10,000 ppm) | >240min | >240min | >240min |
| Doxorubicin HCl (Adriamycin), 2mg/mL (2,000 ppm) | >240min | >240min | >240min |
| Etoposide (Toposar), 20mg/mL (20,000 ppm) | >240min | >240min | >240min |
| Fluorouracil (5 Flu), 50mg/mL (50,000 ppm) | >240min | >240min | >240min |
| Ifosfamide (IFEX), 50mg/mL (50,000 ppm) | >240min | >240min | >240min |
| Methotrexate, 25mg/mL (25,000 ppm) | >240min | >240min | >240min |
| Mitomycin C, 0.5 mg/mL (500 ppm) | >240min | >240min | >240min |
| Mitoxantrone HCl, 2mg/mL (2,000 ppm) | >240min | >240min | >240min |
| Paclitaxel (Taxol), 6mg/mL (6,000 ppm) | >240min | >240min | >240min |
| Vincristine Sulphate, 1mg/mL (1,000 ppm ) | >240 min | >240 min | >240 min |
| Carmustine, 3.3mg/mL (3,300 ppm) | 40 min | 40 min | 55.2 min |
| Thiotepa, 10mg/mL (10,000 ppm) | 88.6 min | 88.6 min | 88.6 min |
| Fentanyl Citrate Injection, 100mcg/2mL | >240 min | >240 min | >240 min |
| Simulated Gastric Acid Fluid / Fentanyl Citrate Injection Mix 50/50 Solution | >240 min | >240 min | >240 min |
### Analysis #1:
Chemotherapy drugs Fentanyl Citrate and Gastric Acid Fluid - the minimum breakthrough time of subject device was updated based on aged glove testing, which will be reflected in the product labeling when it appears to be in worst-case value. The revised labeling provides a conservative representation of product performance throughout the claimed shelf life and serves as a risk mitigation measure to ensure users are informed of the lowest observed breakthrough time during testing, so this difference does not raise questions of safety and effectiveness.
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510(k) Summary
### 9. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
ASTM D6319-19:2023, Standard Specification for Nitrile Examination Gloves for Medical Application
ASTM D6124-06:2022, Standard Test Method for Residual Powder on Medical Gloves
ASTM D5151-19:2023, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6978-05:2023 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
ASTM D7160-16 (Reapproved 2023), Standard Practice for Determination of Expiration Dating for Medical Gloves
ISO 10993-11: 2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-10: 2020, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
| Test Method | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| ASTM D6319-19 | Physical Dimensions Length | MARIN* - Min 240mmMARIN-XTRA* - Min 295mm | Pass |
| ASTM D6319-19 | Physical Dimensions Palm Width | Minimum: XS:60-80mm, S:70-90mm, M:85-105mm, L: 100-120mm, XL:110-130mm, | Pass |
| ASTM D6319-19 | Physical Dimensions Thickness | Finger: 0.1mm (min)Palm: 0.08mm (min) | Pass |
| ASTM D6319-19 | Physical Properties | Tensile Strength (Min 14MPa) and Elongation (Before Aging 500% and after aging 400%) Min | Pass |
| ASTM D6319-19 ASTM D5151-19 | Water leak test | AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319-19 ASTM D6124-06 | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 | Permeation by Chemotherapy Drugs | Refer above table | Pass |
| ISO 10993-11 | Acute systemic toxicity study | Under the conditions of the study, the device extract does not induce acute systemic toxicity response. | Pass |
| ISO 10993-10 | Skin sensitization | Under the condition of the study, the device is not a sensitizer | Pass |
| ISO 10993-10 | Irritation | Under the condition of the study, the device is not an irritant | Pass |
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510(k) Summary
10. Clinical Test Conclusion
No clinical study is included in this submission.
11. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device (K220547).
Page | 10 of 10
