Gammex PI Hybrid Micro Surgical Gloves are sterile, non-pyrogenic, are intended to be worn by operating room personnel to protect a surgical wound from contamination and have a shelf life of 3 years. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Test chemotherapy drug and concentration Minimum breakthrough detection time in minutes Bleomycin (15.0 mg/ml) >240 Busulfan (6.0 mg/ml) >240 Carboplatin (10.0 mg/ml) >240 Carmustine (3.3 mg/ml) 24.1 Cisplatin (1.0 mg/ml) >240 Cyclophosphamide (20.0 mg/ml) >240 Cytarabine HCl (100.0 mg/ml) >240 Dacarbazine (10.0 mg/ml) >240 Daunorubicin HCl (5.0 mg/ml) >240 Docetaxel (10.0 mg/ml) >240 Doxorubicin HCl (2.0 mg/ml) >240 Epirubicin (2.0 mg/ml) >240 Etoposide (20.0 mg/ml) >240 Fludarabine (25.0 mg/ml) >240 Fluorouracil (50.0 mg/ml) >240 Gemcitabine (38.0 mg/ml) >240 Idarubicin (1.0 mg/ml) >240 Ifosfamide (50.0 mg/ml) >240 Irinotecan (20.0 mg/ml) >240 Mechlorethamine HCI (1.0 mg/ml) >240 Melphalan (5.0mg/ml) >240 Methotrexate (25.0 mg/ml) >240 Mitomycin C (0.5 mg/ml) >240 Mitoxantrone (2.0mg/ml) >240 Oxaliplatin (2.0 mg/ml) >240 Paclitaxel (6.0 mg/ml) >240 Rituximab (10.0 mg/ml) >240 ThioTEPA (10.0 mg/ml) 26.0 Vincristine Sulfate (1.0 mg/ml) >240 Warning: Do not use with Carmustine or ThioTEPA

Device Description

Gammex PI Hybrid Micro Surgical Gloves are sterile and disposable devices. The gloves are made of a synthetic rubber polyisoprene and neoprene blend. Ansell has performed independent laboratory testing to support use with Chemotherapy Drugs and Non-Pyrogenic claims. The glove has a shelf life of 3 years, is brown in color and comes in the following sizes: 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0. Each size is assigned with a model number.

AI/ML Overview

The document provides information on the non-clinical testing conducted for the GAMMEX PI Hybrid Micro surgical gloves. Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Dimensions (ASTM D3767-03)	In accordance with ASTM D3577-19: Standard Specification for Rubber Surgical Gloves.	PASS
Physical Properties (ASTM D3577-19)	Acceptance criteria for tensile strength, ultimate elongation and stress at 500% elongation before and after accelerated aging for synthetic surgical gloves per ASTM D3577-19.	PASS
Freedom from holes (ASTM D5151-19)	In accordance with ASTM D3577-19: Standard Specification for Rubber Surgical Gloves with AQL requirements of 1.5.	PASS
Powder-Free (ASTM D6124)	Meets applicable acceptance criteria for powder free ≤ 2mg per glove per ASTM D3577-19.	PASS
Sterility (ANSI/AAMI/ISO 11137-1:2006)	Meets acceptance criteria requirement of 10-6 SAL per ISO 11137-1: Sterilization for Health Care Products - Radiation - Part 1: Requirements for Development, Validation and Routine Control of A Sterilization Process For Medical Devices.	PASS
Chemotherapy Drug Permeation Test (ASTM D6978-05(2019))	Acceptance Criteria in accordance with ASTM D6978-05(2019): Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. (Specific breakthrough times for each drug are listed in the "Indications for Use" section).	PASS (with specific breakthrough times. Noted that Carmustine (24.1 min) and Thiotepa (26.0 min) have extremely low permeation times, leading to a warning for these drugs.)
ISO in vitro Cytotoxicity (ISO 10993-5)	Acceptance criteria in accordance with ISO 10993-5: Biological Evaluation of Medical Devices, Part 5: Tests for In Vitro Cytotoxicity, 2009.	FAIL (Surfaces at undiluted were found to be cytotoxic (grade 4) to L-929 cells and non-cytotoxic with grade 0 at 1:2, 1:4, 1:8, 1:16, 1:32 and 1;64 dilutions.)
ISO Skin Irritation Study (ISO 10993-10:2010)	Passes Primary Skin Irritation test per ISO 10993-10, Biological Evaluation Of Medical Devices, Part 10: Test for Irritation and Skin Sensitization. Under the conditions of the study, not an irritant.	PASS
ISO Maximization Sensitization Study (ISO 10993-10:2010)	Passes Dermal Sensitization test per ISO 10993-10, Biological Evaluation of medical devices, Part 10: Test for Irritation and Skin Sensitization. Under the conditions of the study, not a sensitizer.	PASS
ISO Acute Systemic Toxicity Study (ISO 10993-11:2017)	Passes Acute Systemic Toxicity Test per ISO 10993-11, Biological Evaluation of medical devices, Part 11: Test for Systemic Toxicity. Under the conditions of the study, there was no mortality or evidence of acute systemic toxicity.	PASS
Material Mediated Pyrogenicity Study (USP <151>)	Passes Material Mediated Pyrogenicity Test per USP <151>. Under the conditions of the study, non-pyrogenic.	PASS
Endotoxin Study	Less than 20.0 EU/device.	PASS

Note regarding Cytotoxicity: Although the in vitro cytotoxicity test showed a "FAIL" at undiluted concentrations, the document states that the extracts were then evaluated by ISO 10993-11 for systemic toxicity, which passed, indicating no systemic response in the animal model. This suggests a different acceptance pathway for cytotoxicity, likely due to further evaluation in an in vivo model.

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the specific sample sizes for each non-clinical test.
The data provenance is from non-clinical tests performed by Ansell Healthcare at independent laboratories. There is no information regarding country of origin, but it is implied to be laboratory-based testing rather than human subject data. The studies are by nature prospective as they are conducted for the purpose of demonstrating safety and performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. These are non-clinical tests based on standardized laboratory methods (e.g., ASTM, ISO, USP), not interpretation by human experts. The "ground truth" is defined by the objective measurement criteria of these standards.

4. Adjudication method for the test set:

This information is not applicable, as the tests are objective measurements according to standardized protocols, not subjective assessments requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable. The device is a surgical glove, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This information is not applicable. The device is a physical product (surgical glove), not an algorithm or software.

7. The type of ground truth used:

The ground truth used for these tests is based on established international and national standards and methodologies (e.g., ASTM, ISO, USP) for evaluating the physical, chemical, and biological properties of medical devices like surgical gloves. These standards define the objective criteria and test methods to determine acceptable performance.

8. The sample size for the training set:

This information is not applicable. This is a physical medical device, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:

This information is not applicable, as it's not a machine learning driven device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 20, 2023

Ansell Healthcare Carson Delaloye Senior Administrator Quality 2301 Robb Drive Reno, Nevada 89523

Re: K231902

Trade/Device Name: GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090) Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO, OPJ Dated: September 21, 2023 Received: September 21, 2023

Dear Carson Delaloye:

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 (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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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-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 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.

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-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).

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Sincerely,

Image /page/2/Picture/3 description: The image shows the text "Bifeng Qian -S" in a large, sans-serif font. The text is black and is set against a white background. The words are arranged horizontally, with "Bifeng" and "Qian" being the most prominent. The "-S" is smaller and slightly offset to the right.

BiFeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery 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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Indications for Use

510(k) Number (if known) K231902

Device Name

GAMMEX PI Hybrid Micro (340002055): GAMMEX PI Hybrid Micro (340002060): GAMMEX PI Hybrid Micro (340002065): GAMMEX PI Hybrid Micro (340002070): GAMMEX PI Hybrid Micro (340002075): GAMMEX PI Hybrid Micro (340002080): GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)

Indications for Use (Describe)

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510KSummary

510(k) Number:

K231902

Submitter:

Ansell Healthcare 2301 Robb Drive Reno, NV 89523

Contact Person(s):

Carson Delaloye Senior Coordinator, Regulatory Affairs Phone: 530-401-8977 Email: carson.delaloye@ansell.com

Date Prepared

October 16, 2023

Name of Device

Trade Names:	GAMMEX PI Hybrid Micro (340002055);
	GAMMEX PI Hybrid Micro (340002060);
	GAMMEX PI Hybrid Micro (340002065);
	GAMMEX PI Hybrid Micro (340002070);
	GAMMEX PI Hybrid Micro (340002075);
	GAMMEX PI Hybrid Micro (340002080);
	GAMMEX PI Hybrid Micro (340002085);
	GAMMEX PI Hybrid Micro (340002090)
Common Name:	Surgeon's Gloves
Classification Name:	Non-Powdered Surgeon's Glove
Classification Regulation:	21 CFR 878.4460
Device Class:	I
Product Code:	KGO, OPJ
Classification Panel:	General and Plastic Surgery

Legally Marketed Predicate Device

K182948
Trade Name:	Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs
Common Name:	Surgeon's Gloves
Classification Name:	Non-Powdered Surgeon's Glove

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Classification Regulation:	21 CFR 878.4460
Device Class:	I
Product Code:	KGO
Classification Panel:	General and Plastic Surgery

Device Description

Indication for Use Statement

Test chemotherapy drug and concentration	Minimum breakthroughdetection time in minutes
Bleomycin (15.0 mg/ml)	>240
Busulfan (6.0 mg/ml)	>240
Carboplatin (10.0 mg/ml)	>240
Carmustine (3.3 mg/ml)	24.1
Cisplatin (1.0 mg/ml)	>240
Cyclophosphamide (20.0 mg/ml)	>240
Cytarabine HCl (100.0 mg/ml)	>240
Dacarbazine (10.0 mg/ml)	>240
Daunorubicin HCl (5.0 mg/ml)	>240
Docetaxel (10.0 mg/ml)	>240
Doxorubicin HCl (2.0 mg/ml)	>240
Epirubicin (2.0 mg/ml)	>240
Etoposide (20.0 mg/ml)	>240
Fludarabine (25.0 mg/ml)	>240
Fluorouracil (50.0 mg/ml)	>240
Gemcitabine (38.0 mg/ml)	>240
Idarubicin (1.0 mg/ml)	>240
Ifosfamide (50.0 mg/ml)	>240
Irinotecan (20.0 mg/ml)	>240
Mechlorethamine HCI (1.0 mg/ml)	>240
Melphalan (5.0mg/ml)	>240
Methotrexate (25.0 mg/ml)	>240

Tested chemotherapy drugs are as follows:

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Mitomycin C (0.5 mg/ml)	>240
Mitoxantrone (2.0mg/ml)	>240
Oxaliplatin (2.0 mg/ml)	>240
Paclitaxel (6.0 mg/ml)	>240
Rituximab (10.0 mg/ml)	>240
ThioTEPA (10.0 mg/ml)	26.0
Vincristine Sulfate (1.0 mg/ml)	>240

Warning: Do not use with Carmustine or ThioTEPA

Technological Characteristics:

Technological Characteristics Comparison Table for Predicate Device

	Predicate Device	Proposed Subject Device	Comparison
Trade name	Gammex PI Hybrid Surgical Gloves Tested forUse with Chemotherapy Drugs	GAMMEX PI Hybrid Micro (340002055);GAMMEX PI Hybrid Micro (340002060);GAMMEX PI Hybrid Micro (340002065);GAMMEX PI Hybrid Micro (340002070);GAMMEX PI Hybrid Micro (340002075);GAMMEX PI Hybrid Micro (340002080);GAMMEX PI Hybrid Micro (340002085);GAMMEX PI Hybrid Micro (340002090)	Different -Trade Nameo The names aredifferent to indicatewhich of the devices isthe smaller version. Thisdoes not affect safety orefficacy as the differenceis to inform the end user.
510k Number	K182948	K231902	Different -New 510(k)
ProductOwner	Ansell Healthcare	Ansell Healthcare	Same
Product Code	KGO	KGO, OPJ	Different -OPJ product codeadded for chemo
RegulationNumber	21 CFR 878.4460	21 CFR 878.4460	Same
RegulatoryClass	I	I	Same
RegulationName	Non-powdered Surgeon's Gloves	Non-powdered Surgeon's glove	Same
Indications forUse	Gammex PI Hybrid Surgical Gloves areintended to be worn by operating roompersonnel to protect a surgical wound fromcontamination. These gloves were tested foruse with Chemotherapy Drugs as per ASTMD6978-05 Standard Practice for Assessment ofMedical Gloves to Permeation byChemotherapy Drugs.Tested chemotherapy drugs are as follows:Test Chemotherapy drug & ConcentrationMinimum Breakthrough Detection Time inMinutesBleomycin sulfate (15.0 mg/ml) >240	Gammex PI Hybrid Micro Surgical Gloves are sterile,non-pyrogenic, are intended to be worn byoperating room personnel to protect a surgicalwound from contamination and have a shelf life of 3years. These gloves were tested for use withChemotherapy Drugs as per ASTM D6978 StandardPractice for Assessment of Medical Gloves toPermeation by Chemotherapy Drugs.Tested chemotherapy drugs are as follows:Test Chemotherapy drug & concentration MinimumBreakthrough detection time in minutesBleomycin sulfate (15.0 mg/ml) >240Busulfan (6.0 mg/ml) >240	DifferentItemized List ofDifferences BetweenPredicate and Proposed:• Indications for Useo The indications for usediffer as the proposeddevice carries non-pyrogenic claims. Thepermeation times alsodiffer for Carmustine andThioTEPA.

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	Busulfan (6.0 mg/ml) >240	Carboplatin (10.0 mg/ml) >240	Carboplatin (10.0 mg/ml) >240	Carmustine (3.3 mg/ml) 24.1	Same
	Carboplatin (10.0 mg/ml) >240	Carmustine (3.3 mg/ml) 23.6	Carmustine (3.3 mg/ml) 24.1	Cisplatin (1.0 mg/ml) >240
	Carmustine (3.3 mg/ml) 23.6	Cisplatin (1.0 mg/ml) >240	Cisplatin (1.0 mg/ml) >240	Cyclophosphamide (20.0 mg/ml) >240
	Cisplatin (1.0 mg/ml) >240	Cyclophosphamide (20.0 mg/ml) >240	Cyclophosphamide (20.0 mg/ml) >240	Cytarbine (100.0 mg/ml) >240
	Cyclophosphamide (20.0 mg/ml) >240	Cytarabine (100.0 mg/ml) >240	Cytarbine (100.0 mg/ml) >240	Dacarbazine (10 mg/ml) >240
	Cytarabine (100.0 mg/ml) >240	Dacarbazine (10 mg/ml) >240	Dacarbazine (10 mg/ml) >240	Daunorubicin (5.0 mg/ml) >240
	Dacarbazine (10 mg/ml) >240	Daunorubicin (5.0 mg/ml) >240	Daunorubicin (5.0 mg/ml) >240	Docetaxel (10.0 mg/ml) >240
	Daunorubicin (5.0 mg/ml) >240	Docetaxel (10.0 mg/ml) >240	Docetaxel (10.0 mg/ml) >240	Doxorubicin Hydrochloride (2.0 mg/ml) >240
	Docetaxel (10.0 mg/ml) >240	Doxorubicin Hydrochloride (2.0 mg/ml) >240	Doxorubicin Hydrochloride (2.0 mg/ml) >240	Epirubicin (2.0 mg/ml) >240
	Doxorubicin Hydrochloride (2.0 mg/ml) >240	Epirubicin (2.0 mg/ml) >240	Epirubicin (2.0 mg/ml) >240	Etoposide (20.0 mg/ml) >240
	Epirubicin (2.0 mg/ml) >240	Etoposide (20.0 mg/ml) >240	Etoposide (20.0 mg/ml) >240	Fludarabine (25.0 mg/ml) >240
	Etoposide (20.0 mg/ml) >240	Fludarabine (25.0 mg/ml) >240	Fludarabine (25.0 mg/ml) >240	Fluorouracil (50.0 mg/ml) >240
	Fludarabine (25.0 mg/ml) >240	Fluorouracil(50.0 mg/ml) >240	Fluorouracil (50.0 mg/ml) >240	Gemcitabine (Gemzar) (38.0 mg/ml) >240
	Fluorouracil(50.0 mg/ml) >240	Gemcitabine (Gemzar) (38.0 mg/ml) >240	Gemcitabine (Gemzar) (38.0 mg/ml) >240	Idarubicin (1.0 mg/ml) >240
	Gemcitabine (Gemzar) (38.0 mg/ml) >240	Idarubicin (1.0 mg/ml) >240	Idarubicin (1.0 mg/ml) >240	Ifosfamide (50.0 mg/ml) >240
	Idarubicin (1.0 mg/ml) >240	Ifosfamide (50.0 mg/ml) >240	Ifosfamide (50.0 mg/ml) >240	Irinotecan (20.0 mg/ml) >240
	Ifosfamide (50.0 mg/ml) >240	Irinotecan (20.0 mg/ml) >240	Irinotecan (20.0 mg/ml) >240	Mechlorethamine HCI (1.0 mg/ml) >240
	Irinotecan (20.0 mg/ml) >240	Mechlorethamine HCl(1.0 mg/ml) >240	Mechlorethamine HCI (1.0 mg/ml) >240	Melphalan (5.0 mg/ml) >240
	Mechlorethamine HCl(1.0 mg/ml) >240	Melphalan (5.0 mg/ml) >240	Melphalan (5.0 mg/ml) >240	Methotrexate (25.0 mg/ml >240
	Melphalan (5.0 mg/ml) >240	Methotrexate (25.0 mg/ml) >240	Methotrexate (25.0 mg/ml) >240	Mitomycin C (0.5 mg/ml) >240
	Methotrexate (25.0 mg/ml) >240	Mitomycin C (0.5 mg/ml) >240	Mitomycin C (0.5 mg/ml) >240	Mitoxantrone (2.0 mg/ml) >240
	Mitomycin C (0.5 mg/ml) >240	Mitoxantrone (2.0 mg/ml) >240	Mitoxantrone (2.0 mg/ml) >240	Oxaliplatin (2.0 mg/ml) >240
	Mitoxantrone (2.0 mg/ml) >240	Oxaliplatin (2.0 mg/ml) >240	Oxaliplatin (2.0 mg/ml) >240	Paclitaxel (Taxol) (6.0 mg/ml) >240
	Oxaliplatin (2.0 mg/ml) >240	Paclitaxel (Taxol) (6.0 mg/ml) >240	Paclitaxel (Taxol) (6.0 mg/ml) >240	Rituximab (10.0 mg/ml) >240
	Paclitaxel (Taxol) (6.0 mg/ml) >240	Rituximab (10.0 mg/ml) >240	Rituximab (10.0 mg/ml) >240	ThioTEPA (10.0 mg/ml) 26.0
	Rituximab (10.0 mg/ml) >240	ThioTEPA (10.0 mg/ml) 36.1	ThioTEPA (10.0 mg/ml) 26.0	Vincristine Sulfate (1.0 mg/ml) >240
	ThioTEPA (10.0 mg/ml) 36.1	Vincrinstine Sulfate(1.0 mg/ml) >240	Vincristine Sulfate (1.0 mg/ml) >240	Warning: Do not use with Carmustine or ThioTEPA
	Vincrinstine Sulfate(1.0 mg/ml) >240		Warning: Do not use with Carmustine or ThioTEPA
MaterialComposition	Synthetic polyisoprene rubber		Synthetic polyisoprene rubber		Same
Coating	Polymer Coating		Polymer Coating		Same
Design	Single use		Single use		Same
	Powder-free		Powder-free		Same
	Hand Specific		Hand Specific		Same
	Beaded cuff		Beaded cuff		Same
	Natural		Brown		Different - ChangedColor
Color
Labeling	Surgeon's Gloves		Surgeon's Gloves		Same
Shelf Life	3 Years		3 Years		Same
Performancea. Dimensions	Meets ASTM D3577-19 (2015) requirements		Meets ASTM D3577-19 requirements		Same
b. PhysicalProperties	Meets ASTM D3577-19 (2015) requirements		Meets ASTM D3577-19 requirements		Same
			Meets ASTM D3577-19 (2015)
c. Freedom from	Meets ASTM D3577-19 (2015)				Same
holes	AQL Meets CFR 800.20 Requirements		AQL Meets CFR 800.20 Requirements
d. Powder	Meet applicable definition for powder free per		Meet applicable definition for powder free per		Same
Residual	ASTM D3577-19; ≤ 2mg per glove		ASTM D3577-19; ≤ 2mg per glove
e. Sterility	Sterile		Sterile		Same
Bio-compatibilitySkin Irritation	Passes Primary Skin Irritation test per ISO10993-10, Biological Evaluation of medical		Passes Primary Skin Irritation test per ISO 10993-10,Biological Evaluation of medical devices, Part 10:Test for irritation and skin sensitization		Same

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Bio-compatibilitySensitization	Passes Dermal Sensitization test per ISO 10993-10, Biological Evaluation of medical devices, Part 10: Test for irritation and skin sensitization	Passes Dermal Sensitization test per ISO 10993-10, Biological Evaluation of medical devices, Part 10: Test for irritation and skin sensitization	Same
Bio-compatibilityAcute SystemicToxicity	Passes Acute Systemic Toxicity Test per ISO 10993-11, Biological Evaluation of medical devices, Part 11: Test for systemic toxicity	Passes Acute Systemic Toxicity Test per ISO 10993-11, Biological Evaluation of medical devices, Part 11: Test for systemic toxicity	Same
Bio-compatibilityCytotoxicity	Under the conditions of the study, the device extract was found to be cytotoxic and therefore the device extracts were evaluated by ISO 10993-11 - Test for systemic toxicity. From the Acute Systemic Toxicity device extracts, the device extracts did not elicit a systemic response in the animal model	Under the conditions of the study, the device extract was found to be cytotoxic and therefore the device extracts were evaluated by ISO 10993-11 - Test for systemic toxicity. From the Acute Systemic Toxicity device extracts, the device extracts did not elicit a systemic response in the animal model	Same
Non-pyrogenic	Not reported	Passes Material Mediated Pyrogenicity Test per USP <151>. Under the conditions of the study, non-pyrogenic.Less than 20.0 EU/device. Under the conditions of the study, low endotoxin levels.	Different
SterilizationMethod	Gamma Irradiation	Gamma Irradiation	Same
SterilizationInformation	Meets ANSI/AAMI/ISO 11137-1:2006 requirement of 10-6 SAL.	Meets ANSI/AAMI/ISO 11137-1:2006 requirement of 10-6 SAL.	Same
Prescription orOver TheCounter	Over the Counter	Over the Counter	Same

ltemized List of Differences Between Predicate and Proposed:

Trade Name
The names are different to indicate which of the devices is the smaller version. This does not affect safety or efficacy as the difference is to inform the end user.
. Indications For Use The indications for use differ as the proposed device carries non-pyrogenic claims. The permeation times also differ for Carmustine and ThioTEPA.
. Color

The color is listed as different for the devices. Brown pigmentation was added to the Proposed Subject device.

Non-pyrogenic
The proposed device has demonstrated low endotoxin levels and did not elicit a pyrogenic response in testing. Testing was not reported for the predicate device.

Non-Clinical Testing

Gammex® Pl Plus Glove-in-Glove™ System Tested for Use with Chemotherapy Drugs has the following technological characteristics as compared to ASTM or equivalent standards:

{10}------------------------------------------------

Results	Title of Test	Purpose of Test	Acceptance Criteria
PASS	ASTMD3767-03	Dimensions	Acceptance criteria in accordance with ASTM D3577-19: StandardSpecification for Rubber Surgical Gloves
PASS	ASTMD3577-19	Physical Properties	Acceptance criteria for tensile strength, ultimate elongation and stressat 500% elongation before and after accelerated aging for syntheticsurgical gloves per ASTM D3577-19: Standard Specification for RubberSurgical Gloves
PASS	ASTMD5151-19	Freedom from holes	Acceptance criteria in accordance with ASTM D3577-19: StandardSpecification for Rubber Surgical Gloves with AQL requirements of 1.5
PASS	ASTM D6124	Powder-Free	Meets applicable acceptance criteria for powder free ≤ 2mg per gloveper ASTM D3577-19: Standard Specification for Rubber Surgical Gloves
PASS	ANSI/AAMI/ ISO11137-1:2006	Sterility	Meets acceptance criteria requirement of 10-6 SAL per ISO 11137-1:Sterilization for Health Care Products - Radiation - Part 1: Requirementsfor Development, Validation and Routine Control of A SterilizationProcess For Medical Devices
PASS	ASTMD6978- 05(2019)	Chemotherapy DrugPermeation Test	Acceptance Criteria in accordance with ASTM D6978-05(2019):Standard Practice for Assessment of Resistance of Medical Gloves toPermeation by Chemotherapy Drugs.*Please note that the following drugs have extremely low permeationtimes: Carmustine (24.1 min) and Thiotepa (26.0 min)
FAIL	ISO 10993-5	ISO in vitro CytotoxicityStudy	Surfaces at undiluted were found to be cytotoxic (grade 4) to L-929cells and non-cytotoxic with grade 0 at 1:2, 1:4, 1:8, 1:16, 1:32 and 1;64dilutions. Acceptance criteria in accordance with ISO 10993-5:Biological Evaluation of Medical Devices, Part 5: Tests for In VitroCytotoxicity, 2009.
PASS	ISO 10993-10:2010	ISO SkinIrritation Study	Passes Primary Skin Irritation test per ISO 10993-10, BiologicalEvaluation Of Medical Devices, Part 10: Test for Irritation and SkinSensitization. Under the conditions of the study, not an irritant.
PASS	ISO 10993-10:2010	ISOMaximizationSensitization Study	Passes Dermal Sensitization test per ISO 10993-10, BiologicalEvaluation of medical devices, Part 10: Test for Irritation and SkinSensitization. Under the conditions of the study, not a sensitizer
PASS	ISO 10993-11:2017	ISO Acute SystemicToxicity Study - ISO10993-11:2017	Passes Acute Systemic Toxicity Test per ISO 10993-11, BiologicalEvaluation of medical devices, Part 11: Test for Systemic Toxicity.Under the conditions of the study, there was no mortality or evidenceof acute systemic toxicity
PASS	USP <151>	Material MediatedPyrogenicity Study -USP <151>	Passes Material Mediated Pyrogenicity Test per USP <151>. Under theconditions of the study, non-pyrogenic.
PASS	Endotoxin Study	Demonstrate lowendotoxin levels	Less than 20.0 EU/device

Clinical Studies

A clinical study was not conducted on the subject device.

Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device, GAMMEX Pl Hybrid Micro, is as safe, as effective, and performs as well as or better than the legally marketed device K182948.

Regulation Number and Section

§ 878.4460 Non-powdered surgeon's glove.

(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).