Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl
Device Facts
| Record ID | K260703 |
|---|---|
| Device Name | Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl |
| Applicant | S&S Glove Corporation |
| Product Code | LZA · General Hospital |
| Decision Date | Jun 3, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| 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 and Fentanyl Citrate using ASTM D6978-05.
Device Story
Disposable, non-sterile, powder-free nitrile examination gloves; available in blue and black; sizes XS-XXL. Used by healthcare professionals in clinical settings to prevent cross-contamination. Tested for permeation resistance against specific chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05. Output is a physical barrier; protects examiner from drug exposure. Warning: Do not use with Carmustine or Thiotepa due to limited breakthrough times.
Clinical Evidence
No clinical data. Bench testing only. Compliance with ASTM D6319-19, ASTM D6124-06, ASTM D5151-19, ASTM D6978-05, and ISO 10993 (10, 11, 23) standards confirmed.
Technological Characteristics
Material: Nitrile. Form: Ambidextrous, powder-free, non-sterile. Dimensions: 220-230mm length, 0.05mm minimum thickness. Tensile strength: 14MPa (min). Elongation: 500% (before aging), 400% (after aging). Standards: ASTM D6319-19, ASTM D6978-05, ASTM D5151-19, ASTM D6124-06, ISO 10993-10/11/23.
Indications for Use
Indicated for use as a disposable medical glove worn by examiners to prevent cross-contamination between patient and examiner. Suitable for use with specific chemotherapy drugs and Fentanyl Citrate.
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
- Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K232266)
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
June 3, 2026
S&S Glove Corporation
% Ray Wang
General Manager
Beijing Believe-Med Technology Service Co., Ltd.
Contact Address
Re: K260703
Trade/Device Name: Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl
Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl
Regulation Number: 21 CFR 880.6250
Regulation Name: Non-Powdered Patient Examination Glove
Regulatory Class: Class I, reserved
Product Code: LZA, LZC, QDO, OPJ
Dated: April 28, 2026
Received: April 28, 2026
Dear Ray Wang:
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.
{1}
K260703 - Ray Wang
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
{2}
K260703 - Ray Wang
Page 3
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-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,
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
{3}
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
# Indications for Use
510(k) Number (if known)
K260703
Device Name
Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;
Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl
Indications for Use (Describe)
Powder Free Blue Nitrile Examination Glove- Tested for Use with Chemotherapy Drugs and Fentanyl:
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 and Fentanyl Citrate using ASTM D6978-05.
The following chemicals have been tested with these gloves:
| Chemotherapy Drugs | Concentration mg/ml | Breakthrough Detection Time in Minutes |
| --- | --- | --- |
| 1 Carmustine, | 3.3mg/ml (3,300 ppm) | 22.7 min |
| 2 Cisplatin, | 1mg/ml (1,000 ppm) | >240min |
| 3 Cyclophosphamide, | 20mg/ml (20,000 ppm) | >240min |
| 4 Dacarbazine (DTIC), | 10mg/ml (10,000 ppm) | >240min |
| 5 Doxorubicin HCl (Adriamycin), | 2mg/ml (2,000 ppm) | >240min |
| 6 Etoposide (Toposar), | 20mg/ml (20,000 ppm) | >240min |
| 7 Fluorouracil (5 Flu), | 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 Thio-Tepa, | 10mg/ml (10,000 ppm) | 11.1 min |
| 13 Vincristine Sulphate, | 1mg/ml (1,000 ppm ) | >240 min |
| Non-chemotherapy Drugs | Concentration mg/ml | Breakthrough Detection Time in Minutes |
| --- | --- | --- |
| 1 Fentanyl Citrate, | 100mcg/2ml | >240min |
Testing showed an average breakthrough time of 11.1 minutes with Thio-Tepa, 10mg/ml (10,000 ppm) and 22.7 minutes with Carmustine, 3.3mg/ml (3,300 ppm)
Warning: Do not use with Carmustine and Thiotepa
Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl:
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 and Fentanyl Citrate using ASTM D6978-05.
The following chemicals have been tested with these gloves:
| Chemotherapy Drugs | Concentration mg/ml | Breakthrough Detection Time in Minutes |
| --- | --- | --- |
| 1 Carmustine, | 3.3mg/ml (3,300 ppm) | 21.4 min |
| 2 Cisplatin, | 1mg/ml (1,000 ppm) | >240min |
| 3 Cyclophosphamide, | 20mg/ml (20,000 ppm) | >240min |
| 4 Dacarbazine (DTIC), | 10mg/ml (10,000 ppm) | >240min |
| 5 Doxorubicin HCl (Adriamycin), | 2mg/ml (2,000 ppm) | >240min |
| 6 Etoposide (Toposar), | 20mg/ml (20,000 ppm) | >240min |
| 7 Fluorouracil (5 Flu), | 50mg/ml (50,000 ppm) | >240min |
| 8 Methotrexate, | 25mg/ml (25,000 ppm) | >240min |
FORM FDA 3881 (8/23)
Page 1 of 2
PSC Publishing Services (301) 443-6740 EF
{4}
| 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 Thio-Tepa, | 10mg/ml (10,000 ppm) | 15.5 min |
| 13 Vincristine Sulphate, | 1mg/ml (1,000 ppm ) | >240 min |
| Non-chemotherapy Drugs | Concentration mg/ml | Breakthrough Detection Time in Minutes |
| --- | --- | --- |
| 1 Fentanyl Citrate, | 100mcg/2ml | >240min |
Testing showed an average breakthrough time of 15.5 minutes with Thio-Tepa, 10mg/ml (10,000 ppm) and 21.4 minutes with Carmustine, 3.3mg/ml (3,300 ppm).
Warning: Do not 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/23)
Page 2 of 2
PSC Publishing Services (301) 443-6740 EF
{5}
510(k) Summary
The assigned 510(k) Number: K260703
## 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
1. Date of Submission: 04/28/2026
2. Sponsor Identification
**S&S GLOVE CORPORATION**
Lot 4, D6 Street, Dat Do I Industrial Park, Dat Do Commune, Ho Chi Minh City, Vietnam
Postal Code: 70000
Contact Person: Sang Duong Thanh
Position: General Manager
Tel: +84906338314
Email: sangdt@ssglove.vn
3. Designated Submission Correspondent
**Beijing Believe-Med Technology Service Co., Ltd.**
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China, 102401
Contact Person: Ray Wang
Position: General Manager
Tel: +86-18910677558
Email: information@believe-med.com
4. Identification of Proposed Device
Trade Name: Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl; Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl
Size(s): XS, S, M, L, XL, XXL
Regulatory Information
Classification Name: Non-Powdered Patient Examination Glove
Classification: I
Page 1 of 9
{6}
510(k) Summary
Product Code: LZA, LZC, QDO, OPJ
Regulation Number: 21 CFR 880.6250
Regulation Name: Non-powdered patient examination glove
Review Panel: General Hospital
5. Identification of Predicate Device(s)
510(k) Number: K232266
Product Name: Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile,
Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Manufacturer: Better Care Plastic Technology Co., Ltd.
6. Device Description:
The Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl and Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl are disposable powder free nitrile examination gloves. There are two colors available: blue and black. They are ambidextrous and come in different sizes: XS, S, M, L, XL and XXL. The gloves are single use only, and provided non-sterile.
The proposed device meets the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05.
Page 2 of 9
{7}
510(k) Summary
# 7. Indication For Use Statement:
# ➤ **Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl:**
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 and Fentanyl Citrate using ASTM D6978-05. The following chemicals have been tested with these gloves:
| No. | Chemotherapy Drugs | Breakthrough Detection Time in Minutes |
| --- | --- | --- |
| 1 | Carmustine, 3.3mg/ml (3,300 ppm) | 22.7 min |
| 2 | Cisplatin, 1mg/ml (1,000 ppm) | > 240min |
| 3 | Cyclophosphamide, 20mg/ml (20,000 ppm) | > 240min |
| 4 | Dacarbazine (DTIC), 10mg/ml (10,000 ppm) | > 240min |
| 5 | Doxorubicin HCl (Adriamycin), 2mg/ml (2,000 ppm) | > 240min |
| 6 | Etoposide (Toposar), 20mg/ml (20,000 ppm) | > 240min |
| 7 | Fluorouracil (5 Flu), 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 | Thio-Tepa, 10mg/ml (10,000 ppm) | 11.1 min |
| 13 | Vincristine Sulphate, 1mg/ml (1,000 ppm ) | > 240 min |
| No. | Non-chemotherapy Drugs | Breakthrough Detection Time in Minutes |
| 1 | Fentanyl Citrate, 100mcg/2ml | > 240min |
Testing showed an average breakthrough time of 11.1 minutes with Thio-Tepa, 10mg/ml (10,000 ppm) and 22.7 minutes with Carmustine, 3.3mg/ml (3,300 ppm).
Warning: Do not use with Carmustine and Thiotepa
# ➤ **Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl:**
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 and Fentanyl Citrate using ASTM D6978-05. The following chemicals have been tested with these gloves:
| No. | Chemotherapy Drugs | Breakthrough Detection Time in Minutes |
| --- | --- | --- |
| 1 | Carmustine, 3.3mg/ml (3,300 ppm) | 21.4 min |
| 2 | Cisplatin, 1mg/ml (1,000 ppm) | > 240min |
| 3 | Cyclophosphamide, 20mg/ml (20,000 ppm) | > 240min |
| 4 | Dacarbazine (DTIC), 10mg/ml (10,000 ppm) | > 240min |
| 5 | Doxorubicin HCl (Adriamycin), 2mg/ml (2,000 ppm) | > 240min |
| 6 | Etoposide (Toposar), 20mg/ml (20,000 ppm) | > 240min |
| 7 | Fluorouracil (5 Flu), 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 | Thio-Tepa, 10mg/ml (10,000 ppm) | 15.5 min |
| 13 | Vincristine Sulphate, 1mg/ml (1,000 ppm ) | > 240 min |
| No. | Non-chemotherapy Drugs | Breakthrough Detection Time in Minutes |
| 1 | Fentanyl Citrate, 100mcg/2ml | > 240min |
Testing showed an average breakthrough time of 15.5 minutes with Thio-Tepa, 10mg/ml (10,000 ppm) and 21.4 minutes with Carmustine, 3.3mg/ml (3,300 ppm).
Warning: Do not Use with Carmustine and Thiotepa
Page 3 of 9
{8}
510(k) Summary
8. Substantially Equivalent (SE) Comparison
Table 1 General Comparison
| ITEM | Proposed Device (K260703) | | Predicate Device (K232266) | Remark |
| --- | --- | --- | --- | --- |
| Trade Name | Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl; | Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl. | Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | |
| 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 | **Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl:** 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 and Fentanyl Citrate using ASTM D6978-05. The following chemicals have been tested with these gloves: | **Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl:** 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 and Fentanyl Citrate using ASTM D6978-05. The following chemicals have been tested with these 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 and Fentanyl Citrate using ASTM D6978-05(2019). The following Chemotherapy Drugs have been tested with these gloves: | Analysis 1 |
Page 4 of 9
{9}
510(k) Summary
| | No. | Chemotherapy Drugs | Breakthrough Detection Time in Minutes | No. | Chemotherapy Drugs | Breakthrough Detection Time in Minutes | Carmustine (HCT) 1.1 mg/ml (1,000 ppm) 1.1 mg/ml (1,000 ppm) 1.1 mg/ml (1,000 ppm) 1.1 mg/ml (1,000 ppm) 1.1 mg/ml (1,000 ppm) 1.1 mg/ml (1,000 ppm) 1.1 mg/ml (1,000 ppm) 1.1 mg/ml (1,000 ppm) 1.1 mg/ml (1,000 ppm) 1 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | Carmustine, 3.3mg/ml (3,000 ppm) | 22.7 min | 1 | Carmustine, 3.3mg/ml (3,000 ppm) | 21.4 min | |
| 2 | Cryphene, 1mg/ml (1,000 ppm) | >240min | 2 | Cryphene, 1mg/ml (1,000 ppm) | >240min | |
| 3 | Cyclophosphamide, 20mg/ml (20,000 ppm) | >240min | 3 | Cyclophosphamide, 20mg/ml (20,000 ppm) | >240min | |
| 4 | Dacarbazine (DTIC), 10mg/ml (10,000 ppm) | >240min | 4 | Dacarbazine (DTIC), 10mg/ml (10,000 ppm) | >240min | |
| 5 | Doxorubicin HCl (Adriamycin), 2mg/ml (2,000 ppm) | >240min | 5 | Doxorubicin HCl (Adriamycin), 2mg/ml (2,000 ppm) | >240min | |
| 6 | Etoposide (Tropical), 20mg/ml (20,000 ppm) | >240min | 6 | Etoposide (Tropical), 20mg/ml (20,000 ppm) | >240min | |
| 7 | Fluorescein (5-Flu), 10mg/ml (10,000 ppm) | >240min | 7 | Fluorescein (5-Flu), 10mg/ml (10,000 ppm) | >240min | |
| 8 | Methoxamine, 25mg/ml (25,000 ppm) | >240min | 8 | Methoxamine, 25mg/ml (25,000 ppm) | >240min | |
| 9 | Mitoxantrone C, 0.5 mg/ml (500 ppm) | >240min | 9 | Mitoxantrone C, 0.5 mg/ml (500 ppm) | >240min | |
| 10 | Mitoxantrone HCl, 2mg/ml (2,000 ppm) | >240min | 10 | Mitoxantrone HCl, 2mg/ml (2,000 ppm) | >240min | |
| 11 | Paclitaxel (Tared), 6mg/ml (6,000 ppm) | >240min | 11 | Paclitaxel (Tared), 6mg/ml (6,000 ppm) | >240min | |
| 12 | Thio-Tepa, 10mg/ml (10,000 ppm) | 11.1 min | 12 | Thio-Tepa, 10mg/ml (10,000 ppm) | 15.5 min | |
| 13 | Vincristine Sulphate, 1mg/ml (1,000 ppm) | >240 min | 13 | Vincristine Sulphate, 1mg/ml (1,000 ppm) | >240 min | |
| No. | Non-chemotherapy Drugs | Breakthrough Detection Time in Minutes | No. | Non-chemotherapy Drugs | Breakthrough Detection Time in Minutes | |
| 1 | Fentanyl Citrate, 100mg/ml | >240min | 1 | Fentanyl Citrate, 100mg/ml | >240min | |
| Testing showed an average breakthrough time of 11.1 minutes with Thio-Tepa, 10mg/ml (10,000 ppm) and 22.7 minutes with Carmustine, 3.3mg/ml (3,300 ppm)*Warning: Do not use with Carmustine and Thiotepa. | Testing showed an average breakthrough time of 15.5 minutes with Thio-Tepa, 10mg/ml (10,000 ppm) and 21.4 minutes with Carmustine, 3.3mg/ml (3,300 ppm) *Warning: Do not use with Carmustine and Thiotepa. | Please note that the following drugs have extremely low permeation times: Carmustine: 22.8 minutes, Thiotepa: 46.9 minutes, Or *Warning: Do not use with Carmustine and Thiotepa. |
| Material | Nitrile | Nitrile | Nitrile | SAME |
| Powder or Powder Free | Powder Free | Powder Free | Powder Free | SAME |
| Color | Blue | Black | Blue | Analysis 2 |
| Single use | Single use | Single use | Single use | SAME |
| Biocompatibility | Acute Systemic Toxicity ISO 10993-11:2017 Skin Sensitization ISO 10993-10: 2021 Irritation ISO 10993-23: 2021 | Acute Systemic Toxicity ISO 10993-11: 2017 Skin Sensitization ISO 10993-10: 2021 Irritation ISO 10993-23: 2021 | Acute Systemic Toxicity ISO10993-11:2017 Skin Sensitization ISO 10993-10: 2021 Irritation ISO 10993-23: 2021 | SAME |
| Chemotherapy Drugs and Fentanyl Citrate Claim | Refer to Table 3 | Refer to Table 3 | Refer to Table 3 | Analysis 1 |
Page 5 of 9
{10}
510(k) Summary
Table 2 Technological Characteristic Comparison
| Technological Characteristics | Proposed Device (K260703) | | Predicate Device (K232266) | Remark |
| --- | --- | --- | --- | --- |
| | Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl; | Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl. | Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | |
| Physical Dimension: | | | | |
| Length | Minimum 220mm for size XS and S, 230mm for size M, L, XL, XXL | Minimum 220mm for size XS and S, 230mm for size M, L, XL, XXL | Min 220mm for size XS, S Min 230mm for size M-XXL | SAME |
| Palm Width (size) (mm): | | | | |
| XS | 70±10 | 70±10 | 70±10 | SAME |
| S | 80±10 | 80±10 | 80±10 | SAME |
| M | 95±10 | 95±10 | 95±10 | SAME |
| L | 110±10 | 110±10 | 110±10 | SAME |
| XL | 120±10 | 120±10 | 120±10 | SAME |
| XXL | 130±10 | 130±10 | 130±10 | SAME |
| Thickness (mm): | | | | |
| Finger | Minimum 0.05 | Minimum 0.05 | Minimum 0.05 | SAME |
| Palm | Minimum 0.05 | Minimum 0.05 | Minimum 0.05 | 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 |
Page 6 of 9
{11}
510(k) Summary
Table 3 Chemotherapy Permeation and Fentanyl Citrate Comparison
| Tested Chemotherapy Drug and Fentanyl Citrate Concentration | Minimum BDT (Minutes) | | |
| --- | --- | --- | --- |
| | Proposed Device (K260703) | | Predicate Device (K232266) |
| | Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl; | Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl; | Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
| Bleomycin Sulfate 15mg/ml (15000 ppm) | | | >240 |
| Busulfan 6mg/ml (6,000 ppm) | | | >240 |
| Carboplatin 10mg/ml (10,000 ppm) | | | >240 |
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | 22.7 | 21.4 | 22.8 |
| Chloroquine 50mg/ml (50,000ppm) | | | >240 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 | >240 | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 | >240 |
| Cyclosporin 100 mg/ml (100,000 ppm) | | | >240 |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | | | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 | >240 | >240 |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | | | >240 |
| Docetaxel, 10 mg/ml (10,000 ppm) | | | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | >240 |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | | | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 | >240 |
| Fludarabine, 25 mg/ml (25,000 ppm) | | | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 | >240 | >240 |
| Gemcitabine, 38mg/ml (38,000ppm) | | | >240 |
| Idarubicin HCL, 1mg/ml (1,000ppm) | | | >240 |
| Ifosfamide, 50mg/ml (50,000ppm) | | | >240 |
| Irinotecan, 20mg/ml (20,000ppm) | | | >240 |
| Mechlorethamine HCl, 1mg/ml (1,000ppm) | | | >240 |
| Melphalan, 5mg/ml (5,000ppm) | | | >240 |
Page 7 of 9
{12}
510(k) Summary
| Methotrexate, 25mg/ml (25,000ppm) | >240 | >240 | >240 |
| --- | --- | --- | --- |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 | >240 | >240 |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 | >240 | >240 |
| Oxaliplatin, 5mg/ml (5,000ppm) | | | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 | >240 |
| Paraplatin, 10mg/ml (10,000ppm) | | | >240 |
| Retrovir, 10mg/ml (10,000ppm) | | | >240 |
| Rituximab, 10mg/ml (10,000ppm) | | | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 11.1 | 15.5 | 46.9 |
| Topotecan, 1mg/ml (1,000ppm) | | | >240 |
| Trisenox, 1mg/ml (1,000ppm) | | | >240 |
| Velcade, 1mg/ml (1,000ppm) | | | >240 |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 | >240 | >240 |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 | >240 | >240 |
# Analysis #1:
Chemotherapy drugs and Fentanyl Citrate and the minimum breakthrough time of subject device will be listed on labeling, so this difference does not raise questions of safety and effectiveness.
# Analysis #2:
The proposed device has one more color than the predicate device. However, the size specifications for the two colors of the proposed device are the same, with the only difference being the color. We have tested the biocompatibility and performance of the black gloves, and the results meet the requirements. The concentration test results of chemotherapy drugs and fentanyl according to ASTM D6978-05 have also been added to the label. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
# 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
Page 8 of 9
{13}
510(k) Summary
- 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
- ISO 10993-11: 2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- ISO 10993-10: 2021, Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- ISO 10993-23: 2021, Biological evaluation of medical devices - Part 23: Tests for irritation
| Test Method | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| ASTM D6319-19 | Physical Dimensions Length | Min 220mm for size XS, S Min 230mm for size M-XXL | Pass |
| ASTM D6319-19 | Physical Dimensions Palm Width | XS: 70±10mm, S: 80±10mm, M: 95±10mm, L: 110±10mm, XL:120±10mm, XXL:130±10mm | Pass |
| ASTM D6319-19 | Physical Dimensions Thickness | Finger: 0.05mm (min) Palm: 0.05mm (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 10993-23 | Irritation | Under the condition of the study, the device is not an irritant | Pass |
# 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 (K232266).
Page 9 of 9
