PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves

Q: Who is the manufacturer of PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves?

O&M Halyard, Inc. filed the 510(k) submission for PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves (K220541).

Q: What is the FDA product code for PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves?

LZA. It is classified under 21 CFR 880.6250 as a Class 1 device in the General Hospital panel.

Q: What is the regulatory pathway for PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves?

510(k) clearance (submission type: Special).

Q: Who can help prepare an FDA 510(k) submission like PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K220541 · O&M Halyard, Inc. · LZA · Jun 2, 2022 · General Hospital

Device Facts

Record ID	K220541
Device Name	PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves
Applicant	O&M Halyard, Inc.
Product Code	LZA · General Hospital
Decision Date	Jun 2, 2022
Decision	SESE
Submission Type	Special
Regulation	21 CFR 880.6250
Device Class	Class 1

Intended Use

The PureZero LIMON Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim and PureZero LIMON-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.

Device Story

Disposable nitrile examination gloves; green, chlorinated, powder-free, textured fingertip, ambidextrous. Used by clinicians in medical settings to prevent cross-contamination. Provides barrier protection against patient fluids and specific chemical agents. Subject device tested for permeation resistance against chemotherapy drugs, fentanyl citrate, and gastric acid per ASTM D6978-05. Output is a physical barrier; healthcare providers use the glove during patient examinations or handling of hazardous drugs to reduce exposure risk. Benefits include protection of both patient and examiner from contamination.

Clinical Evidence

Bench testing only. No clinical data. Testing included ASTM D6978-05 (chemotherapy drug permeation), ASTM D5151-06 (leakage/pinholes), ASTM D6124-06 (residual powder), ASTM D6319-10 (physical dimensions/tensile strength), and ISO 10993 (biocompatibility: irritation, sensitization, systemic toxicity). Results met all acceptance criteria.

Technological Characteristics

Nitrile rubber material; powder-free; chlorinated; textured fingertips. Non-sterile. Dimensions: 9.5 inches (LIMON) or 12 inches (LIMON-XTRA). Complies with ASTM D6319, D5151, D6124, D6978, and ISO 10993 standards.

Indications for Use

Indicated for use as a disposable patient examination glove worn by medical examiners to prevent cross-contamination between patient and examiner. Tested for resistance to permeation by specific chemotherapy drugs, fentanyl citrate, and gastric acid.

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

Halyard Sterling* Nitrile Powder-Free Exam Glove with Chemotherapy Drug and Fentanyl Citrate Claim (K191230)

Related Devices

K200633 — Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove · 0 & M Halyard, Inc. · Oct 11, 2020
K232538 — DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL · Wrp Asia Pacific Sdn. Bhd. · Nov 17, 2023
K230847 — Chemotherapy Gloves · 3A Glove Sdn. Bhd. · Sep 29, 2023
K201390 — Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) · Medline Industires, Inc. · Sep 18, 2020
K161929 — Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove · Dipped Products (Thailand) Limited · Mar 29, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. June 2, 2022 ೦&M Halyard, Inc. Angela Bunn Director. Global Regulatory Affairs 1 Edison Drive Alpharetta, Georgia 30005 Re: K220541 Trade/Device Name: PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, QDO Dated: April 28, 2022 Received: May 3, 2022 Dear Angela Bunn: 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 (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 located 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. 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 {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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, For Bifeng Oian, Ph D Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use ### 510(k) Number (if known) #### K220541 #### Device Name The PureZero LIMON Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim and PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves #### Indications for Use (Describe) The PureZero LIMON Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim and PureZero LIMON-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. The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: | Cisplatin (1 mg/ml) | Cyclophosphamide (20 mg/ml) | |-------------------------------------------|----------------------------------------------------------------------------| | Dacarbazine (10 mg/ml) | Doxorubicin HCI (2 mg/ml) | | Etoposide (20 mg/ml) | Fluorouracil (50 mg/ml) | | Ifosfamide (50 mg/ml) | Methotrexate (25 mg/ml) | | Mitomycin C (0.5 mg/ml) | Mitoxantrone HCI (2 mg/ml) | | Paclitaxel (6 mg/ml) | Vincrinstine Sulfate (1 mg/ml) | | Fentanyl Citrate Injection (100 mcg/2 mL) | Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes: ThioTEPA (10 mg/ml), breakthrough detected at 87.6 minutes Carmustine (3.3 mg/ml), breakthrough detected at 34.3 minutes Warning: Not for Use With: Carmustine, 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. {3}------------------------------------------------ {4}------------------------------------------------ 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 Druq 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." {5}------------------------------------------------ # 510(k) Summary # K220541 | Date Summary was Prepared | February 10, 2022 | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Submitter | O & M Halyard, Inc. 1 Edison Drive Alpharetta, GA 30005 | | Primary Contact for this 510(k) Submission | Angela L. Bunn, RAC Tel: 470-347-7147 Email: angela.bunn@owens-minor.com | | Marketed Common Name | Nitrile Powder-Free Exam Gloves | | Device Submission Trade Name and Description | PureZero LIMON Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim | | | PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim | | Device Common Name | Patient Examination Gloves | | Device Product Code and Classification Name | LZA Class I, 21 CFR §880.6250 Patient Examination Glove LZC Class I, 21 CFR §880.6250 Patient Examination Glove, Specialty QDO Class 1, 21 CFR §880.6250 Fentanyl and Other Opioid Protection Glove | | Predicate Device | Halyard Sterling* Nitrile Powder-Free Exam Glove with Chemotherapy Drug and Fentanyl Citrate Claim (K191230) | | Subject Device Description | The subject device is a green colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, patient examination gloves. The devices follow consensus standards: ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves | | | ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Applications | | | ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves | | | ASTM D6978-05 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: 2010: Biological evaluation of medical devices - Part 10: | | | | | Indications for Use | Tests for Irritation and Skin Sensitization The PureZero LIMON Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim and PureZero LIMON-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. | | | The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: | | | Cisplatin (1 mg/ml) | | | Cyclophosphamide (20 mg/ml) | | | Dacarbazine (10 mg/ml) | | | Doxorubicin HCI (2 mg/ml) | | | Etoposide (20 mg/ml) | | | Fluorouracil (50 mg/ml) | | | Ifosfamide (50 mg/ml) | | | Methotrexate (25 mg/ml) | | | Mitomycin C (0.5 mg/ml) | | | Mitoxantrone HCI (2 mg/ml) | | | Paclitaxel (6 mg/ml) | | | Vincrinstine Sulfate (1 mg/ml) | | | Fentanyl Citrate Injection (100 mcg/2 mL) | | | Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | | | The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes: | | | ThioTEPA (10 mg/ml), breakthrough detected at 87.6 minutes Carmustine (3.3 mg/ml), breakthrough detected at 34.3 minutes Warning: Not for Use With: Carmustine or ThioTEPA | {6}------------------------------------------------ | Technological Characteristics Comparison Table | | | | |------------------------------------------------|---------------------------|------------------------------------------------------------------------------------|------------------------------------------------| | | Subject Device K220541 | Predicate Device Halyard Sterling* Nitrile Powder-Free Exam Glove K191230 | Comparison | | FDA Product Code | LZC, LZA, QDO | LZC | Added LZA and QDO for the Fentanyl Claim | | FDA Classification | Class I | Class I | Same | | Regulation Number | 880.6250 | 880.6250 | Same | | Common Name | Patient Examination Glove | Patient Examination Glove | Same | {7}------------------------------------------------ | Device Trade Name | PureZero LIMON Nitrile Powder- Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim | Halyard Sterling* Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs and Fentanyl Citrate claim | Similar | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------| | Intended Use | The device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, fentanyl citrate and gastric acid as listed on the label. | The device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs and fentanyl citrate listed on the label. | Similar Adding Gastric Acid Claim | | Technological Characteristics | The glove is a colored, nitrile, powder-free, textured fingertip, ambidextrous, patient examination glove. | The glove is a colored, nitrile, powder-free, textured fingertip, ambidextrous, patient examination glove. | Same | | Sizes of gloves | XS, S, M, L, XL | XS, S, M, L, XL | Same | | Glove Length | PureZero LIMON Nitrile Powder- Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim is 9.5 inches in length PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim is 12 inches in length | Halyard Sterling* Nitrile Powder-Free Exam Glove with Chemotherapy Drugs and Fentanyl Citrate is 9.5 inches in length | Similar Adding a longer length glove | | Texture | Textured fingertips | Textured fingertips | Same | | Sterility | Non-Sterile | Non-Sterile | Same | | Shelf Life | 3-year | None | Different | | Biocompatibility | Based ISO 10993-11 Biological evaluation of Medical devices - Test for Systemic Toxicity, the test article was considered non- toxic. Meets the acceptance criteria. | Based ISO 10993-11 Biological evaluation of Medical devices - Test for Systemic Toxicity, the test article was considered non- toxic. Meets the acceptance criteria. | Same | | | Based on ISO 10993-10 Biological evaluation of Medical Devices - Test for Skin Irritation, the test article was considered nonirritating. Meets the acceptance criteria. | Based on ISO 10993-10 Biological evaluation of Medical Devices - Test for Skin Irritation, the test article was considered nonirritating. Meets the acceptance criteria. | | | | Based on ISO 10993-10 Biological evaluation of Medical Devices - Test for Skin Sensitization. Under the conditions of the study the device is not a sensitizer. Meets the acceptance criteria. | Based on ISO 10993-10 Biological evaluation of Medical Devices - Test for Skin Sensitization. Under the conditions of the study the device is not a sensitizer. Meets the acceptance criteria. | | {8}------------------------------------------------ {9}------------------------------------------------ | Standard | Results Subject Device(s) | Results Predicate Device K191230 | Remarks | |-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Standard | PureZero LIMON Nitrile Powder- Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim | Halyard Sterling* Nitrile Powder- Free Exam Glove with Chemotherapy Drugs and Fentanyl Citrate claim | | | ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs | The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Cisplatin (1 mg/ml) Cyclophosphamide (20 mg/ml) Dacarbazine (10 mg/ml) Doxorubicin HCI (2 mg/ml) Etoposide (20 mg/ml) Fluorouracil (50 mg/ml) Ifosfamide (50 mg/ml) Methotrexate (25 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone HCI (2 mg/ml) Paclitaxel (6 mg/ml) Vincrinstine Sulfate (1 mg/ml) Fentanyl Citrate Injection (100 mcg/2 mL) Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Arsenic Trioxide (1 mg/ml) Doxorubicin HCL (2 mg/ml) Paclitaxel (6 mg/ml) Azacitidine (Vidaza) (25 mg/ml) Epirubicin (Ellence) (2 mg/ml) Paraplatin (10 mg/ml) Bendamustine (5 mg/ml) Eribulin Mesylate (0.5 mg/ml) Pemetrexed (25 mg/ml) Bortezomib (Velcade) (1 mg/ml) Etoposide (20 mg/ml) Pertuzumab (30 mg/ml) Bleomycin sulfate (15 mg/ml) Fludarabine (25 mg/ml) Raltitrexed (0.5 mg/ml) Busulfan (6 mg/ml) Fluorouracil (50 mg/ml) Retrovir (10 mg/ml) Carboplatin (10 mg/ml) Fulvestrant (50 mg/ml) Rituximab (10 mg/ml) Carfilzomib (2 mg/ml) Gemcitabine (38 mg/ml) Temsirolimus (25 mg/ml) Cetuximab (Erbitux) (2 mg/ml) Idarubicin (1 mg/ml) Trastuzumab (21 mg/ml) Cisplatin (1 mg/ml) Ifosfamide (50 mg/ml) | Similar | | | The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes: ThioTEPA (10 mg/ml), breakthrough detected at 87.6 minutes Carmustine (3.3 mg/ml), breakthrough detected at 34.3 minutes. | | | {10}------------------------------------------------ | Cyclophosphamide (20 mg/ml) | | |---------------------------------------------------------------------|--| | Irinotecan (20 mg/ml) | | | Triclosan (2 mg/ml) | | | Cytarabine HCL (100 mg/ml) | | | Mechlorethamine HCL (1 mg/ml) | | | Trisonex (1 mg/ml) | | | Cytovene (10 mg/ml) | | | Melphalan (5 mg/ml) | | | Vincrinstine Sulfate (1 mg/ml) | | | Dacarbazine (10 mg/ml) | | | Methotrexate (25 mg/ml) | | | Vinblastine (1 mg/ml) | | | Daunorubicin HCL (5 mg/ml) | | | Mitomycin-C (0.5 mg/ml) | | | Vinorelbine (10 mg/ml) | | | Decitabine (5 mg/ml) | | | Mitoxantrone (2 mg/ml) | | | Zoledronic Acid (0.8 mg/ml) | | | Docetaxel (10 mg/ml) | | | Oxaliplatin (2 mg/ml) | | | ThioTEPA (10 mg/ml), breakthrough detected at 37.1 minutes | | | Carmustine (3.3 mg/ml), breakthrough detected at 22.9 minutes | | | Performance Data | | | | |-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves | Testing of the subject device shows it meets the 2.5% AQL requirement in the standards for leakage. The device meets the acceptance criteria of the standard. | Testing of the subject device shows it meets the 2.5% AQL requirement in the standards for leakage. The device meets the acceptance criteria of the standard. | Same | | ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves | Residual powder on the subject device is an average of 0.4 mg/glove within the powder-free limit of < 2 mg maximum powder per glove and meets the acceptance criteria for powder- free. | Residual powder on the subject device is an average of 0.4 mg/glove within the powder-free limit of < 2 mg maximum powder per glove and meets the acceptance criteria for powder- free. | Same | {11}------------------------------------------------ | ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Applications | The physical dimensions of the subject device are within the limits of the standard and the physical properties of the subject device met the requirements for tensile strength before and after aging. | The physical dimensions of the predicate device are within the limits of the standard and the physical properties of the subject device met the requirements for tensile strength before and after aging. | Same | |-------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | ISO 10993 Biological evaluation of medical devices | Meets acceptance criteria | Meets acceptance criteria | Same | ## performance characteristics of the subject device | Brief description of non-clinical tests: | Test | Standard | Acceptance Criteria | Results | |------------------------------------------------|---------------------|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------| | | Dimensions | ASTM D 6319 | | Meets requirements | | | | Length | 235 -250 mm (PureZero LIMON Nitrile) | | | | | Palm Width Size | 295- 325 mm (PureZero LIMON-XTRA Nitrile) XSmall: 60 – 80 mm Small: 70 - 90 mm Med: 85–105 mm Large: 100 - 120 mm X-Large: 110-130 mm | | | | | Finger thickness | 0.10-0.19 mm | | | | | Palm thickness | 0.10-0.16 mm | | | | | Cuff thickness | 0.10-0.13 mm | | | | | | | | | | Physical Properties | ASTM D 6319 | AQL 4.0 Before Tensile Strength: ≥14 MPa Ultimate elongation: ≥500% After | Meets requirements | | | | | | | {12}------------------------------------------------ | | | Tensile Strength: ≥14 MPa Ultimate elongation: ≥400% | | |-------------------------------------|----------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | Freedom from Pinholes | ASTM D 6319 ASTM D 5151 | AQL 2.5% No leakage | Meets requirements | | Power Free | ASTM D 6124 ASTM D 6319 | ≤ 2 mg / glove | Meets requirements | | ISO Indirect Irritation Study | ISO 10993, Part 10 | Primary Irritation Index ≤ 2.0 | Under the conditions of The study the device is not an irritant | | ISO Systemic Toxicity Study | ISO 10993, Part 11 | No animals treated with test extracts exhibit greater reaction than control animals | No evidence of systemic toxicity | | ISO Dermal Sensitization | ISO 10993, Part 10 | Grade < 1 | Under the conditions of the study the device is not a sensitizer | | Conclusion: | The conclusions drawn from the nonclinical tests demonstrate that the subject device PureZero LIMON Nitrile Powder- Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim and PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim, are as safe, as effective, and performs as well as or better than the legally marketed devices cleared under K191230. | |-------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Welcome

Check your email

Welcome!