K Number

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)

Manufacturer

Ansell Healthcare

Date Cleared

2023-10-20

(114 days)

Product Code

KGO OPJ

Regulation Number

878.4460

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K182948

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and chemical properties of surgical gloves, with no mention of AI or ML technology.

Therapeutic

No
The device, surgical gloves, is intended to protect the surgical wound from contamination, not to treat a disease or condition for therapeutic benefit.

Diagnostic

The device description clearly states "Gammex PI Hybrid Micro Surgical Gloves" are intended to be worn for protection, not for diagnosing conditions or diseases.

SaMD (Software as a Medical Device)

The device described is a physical medical device (surgical gloves) and does not involve any software component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is clearly stated as being worn by operating room personnel to protect a surgical wound from contamination. This is a barrier function, not a diagnostic one.
Device Description: The description focuses on the material, sterility, and physical properties of the gloves. There is no mention of any components or functions related to analyzing samples from the human body.
Performance Studies: The performance studies listed are related to the physical integrity, safety, and barrier properties of the gloves (e.g., freedom from holes, chemotherapy drug permeation, cytotoxicity, irritation). There are no studies related to diagnostic accuracy or the analysis of biological samples.
Lack of Diagnostic Function: An IVD is a medical device intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such examination.

Therefore, the Gammex PI Hybrid Micro Surgical Gloves are classified as a medical device, specifically a surgical glove, but not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 HCl (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

Product codes (comma separated list FDA assigned to the subject device)

KGO, OPJ

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

operating room personnel

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Testing:

Study Type: Dimensions
- Key Result: PASS (Meets ASTM D3767-03 and ASTM D3577-19 requirements)
Study Type: Physical Properties
- Key Result: PASS (Meets ASTM D3577-19 requirements for tensile strength, ultimate elongation, and stress at 500% elongation)
Study Type: Freedom from holes
- Key Result: PASS (Meets ASTM D5151-19 and ASTM D3577-19 with AQL requirements of 1.5)
Study Type: Powder-Free
- Key Result: PASS (Meets ASTM D6124 and ASTM D3577-19 requirements, ≤ 2mg per glove)
Study Type: Sterility
- Key Result: PASS (Meets ANSI/AAMI/ISO 11137-1:2006 requirement of 10-6 SAL)
Study Type: Chemotherapy Drug Permeation Test
- Key Result: PASS (Meets ASTM D6978-05(2019) requirements. Carmustine: 24.1 min, Thiotepa: 26.0 min, others >240 min. Note: Carmustine and Thiotepa have extremely low permeation times.)
Study Type: ISO in vitro Cytotoxicity Study
- Key Result: FAIL for undiluted (grade 4 cytotoxic to L-929 cells); PASS for dilutions (non-cytotoxic with grade 0 at 1:2 to 1:64 dilutions).
Study Type: ISO Skin Irritation Study
- Key Result: PASS (Not an irritant per ISO 10993-10)
Study Type: ISO Maximization Sensitization Study
- Key Result: PASS (Not a sensitizer per ISO 10993-10)
Study Type: ISO Acute Systemic Toxicity Study
- Key Result: PASS (No mortality or evidence of acute systemic toxicity per ISO 10993-11)
Study Type: Material Mediated Pyrogenicity Study - USP
- Key Result: PASS (Non-pyrogenic per USP )
Study Type: Endotoxin Study
- Key Result: PASS (Less than 20.0 EU/device, demonstrates low endotoxin levels)

Clinical Studies:
A clinical study was not conducted on the subject device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K182948

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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

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).

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

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)

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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

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

Tested chemotherapy drugs are as follows:

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 for
Use 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 Name
o 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.
510k Number	K182948	K231902	Different -New 510(k)
Product
Owner	Ansell Healthcare	Ansell Healthcare	Same
Product Code	KGO	KGO, OPJ	Different -OPJ product code
added for chemo
Regulation
Number	21 CFR 878.4460	21 CFR 878.4460	Same
Regulatory
Class	I	I	Same
Regulation
Name	Non-powdered Surgeon's Gloves	Non-powdered Surgeon's glove	Same
Indications for
Use	Gammex PI Hybrid Surgical Gloves are
intended to be worn by operating room
personnel to protect a surgical wound from
contamination. These gloves were tested for
use with Chemotherapy Drugs as per ASTM
D6978-05 Standard Practice for Assessment of
Medical Gloves to Permeation by
Chemotherapy Drugs.
Tested chemotherapy drugs are as follows:
Test Chemotherapy drug & Concentration
Minimum Breakthrough Detection Time in
Minutes
Bleomycin sulfate (15.0 mg/ml) >240	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 & concentration Minimum
Breakthrough detection time in minutes
Bleomycin sulfate (15.0 mg/ml) >240
Busulfan (6.0 mg/ml) >240	Different
Itemized List of
Differences Between
Predicate and Proposed:
• Indications for Use
o The indications for use
differ as the proposed
device carries non-
pyrogenic claims. The
permeation times also
differ for Carmustine and
ThioTEPA.

	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
Material
Composition	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 - Changed
Color
Color
Labeling	Surgeon's Gloves		Surgeon's Gloves		Same
Shelf Life	3 Years		3 Years		Same
Performance
a. Dimensions	Meets ASTM D3577-19 (2015) requirements		Meets ASTM D3577-19 requirements		Same
b. Physical
Properties	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-
compatibility
Skin Irritation	Passes Primary Skin Irritation test per ISO
10993-10, 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

| Bio-
compatibility

Sensitization	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-
compatibility
Acute Systemic
Toxicity	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-
compatibility
Cytotoxicity	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 . Under the conditions of the study, non-pyrogenic.
Less than 20.0 EU/device. Under the conditions of the study, low endotoxin levels.	Different
Sterilization
Method	Gamma Irradiation	Gamma Irradiation	Same
Sterilization
Information	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 or
Over The
Counter	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:

Results	Title of Test	Purpose of Test	Acceptance Criteria
PASS	ASTM
D3767-03	Dimensions	Acceptance criteria in accordance with ASTM D3577-19: Standard
Specification for Rubber Surgical Gloves
PASS	ASTM
D3577-19	Physical Properties	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: Standard Specification for Rubber
Surgical Gloves
PASS	ASTM
D5151-19	Freedom from holes	Acceptance criteria in accordance with ASTM D3577-19: Standard
Specification for Rubber Surgical Gloves with AQL requirements of 1.5
PASS	ASTM D6124	Powder-Free	Meets applicable acceptance criteria for powder free ≤ 2mg per glove
per ASTM D3577-19: Standard Specification for Rubber Surgical Gloves
PASS	ANSI/AAMI/ ISO
11137-
1:2006	Sterility	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	ASTM
D6978- 05(2019)	Chemotherapy Drug
Permeation Test	Acceptance Criteria in accordance with ASTM D6978-05(2019):
Standard Practice for Assessment of Resistance of Medical Gloves to
Permeation by Chemotherapy Drugs.
*Please note that the following drugs have extremely low permeation
times: Carmustine (24.1 min) and Thiotepa (26.0 min)
FAIL	ISO 10993-5	ISO in vitro Cytotoxicity
Study	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. Acceptance criteria in accordance with ISO 10993-5:
Biological Evaluation of Medical Devices, Part 5: Tests for In Vitro
Cytotoxicity, 2009.
PASS	ISO 10993-
10:2010	ISO Skin
Irritation Study	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 10993-
10:2010	ISO
Maximization
Sensitization Study	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 10993-
11:2017	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	USP	Material Mediated
Pyrogenicity Study -
USP	Passes Material Mediated Pyrogenicity Test per USP . Under the
conditions of the study, non-pyrogenic.
PASS	Endotoxin Study	Demonstrate low
endotoxin 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.