Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm2 per Glove of Extractable Protein

• K Number: K202668
• Device Name: Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm2 per Glove of Extractable Protein
• Manufacturer: Medline Industries, Inc.
• Date Cleared: 2020-12-19 ( 96 days)
• Product Code: KGO LZC
• Regulation Number: 878.4460

Intended Use

The surgeon's glove is a device made of natural rubber latex intended to be worn by surgeon's and or operating room personnel to protect a surgical wound from contamination. In addition these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Description

The surgeon's glove is a device made of natural rubber latex intended to be worn by surgeon's and or operating room personnel to protect a surgical wound from contamination.

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard surgical glove and makes no mention of AI or ML technology.

Therapeutic

No
The device is a surgeon's glove, intended to protect a surgical wound from contamination and for use with chemotherapy drugs, not to treat or cure a disease or condition.

Diagnostic

No

Explanation: The device is a surgeon's glove, intended for protection against contamination, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device is a physical glove made of natural rubber latex, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use is to protect a surgical wound from contamination and for use with chemotherapy drugs. This is a barrier function and protection for the user and patient during a surgical procedure.
• Device Description: The description reinforces the barrier function of the glove.
• Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided text does not mention any such use or interaction with bodily specimens for diagnostic purposes.

The testing for chemotherapy drug permeation is a performance characteristic related to the glove's barrier properties and safety for the user, not a diagnostic function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The surgeon's glove is a device made of natural rubber latex intended to be worn by surgeon's and or operating room personnel to protect a surgical wound from contamination. In addition these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The following chemicals have been tested with these gloves.

Signature Latex

Bleomycin (15 mg/ml) >240 minutes Busulfan (6 mg/ml) >240 minutes Carboplatin (10.0 mg/ml) >240 minutes Carmustine (3.0 mg/ml) 12.6 minutes (12.6, 13.1, 12.7) Cisplatin (1.0 mg/ml)>240 minutes Cyclophosphamide (Cytoxan) (20 mg/ml) >240 minutes Cytarabine 100 mg/ml >240 minutes Dacarbazine (DTIC) (10.0 mg/ml) >240 minutes Doxorubicin Hydrochloride (2.0 mg/ml) >240 minutes Epirubicin (Ellence) (2 mg/ml) >240 minutes Etoposide (Toposar) (20.0 mg/ml) >240 minutes Fludarabine (25.0 mg/ml)>240 minutes Fluorouracil (50.0 mg/ml)>240 minutes Idarubicin (1.0 mg/ml) >240 minutes Ifosfamide (50.0 mg/ml) >240 minutes Mechlorethamine HCI (1.0 mg.ml) >240 minutes Melphalan (5 mg/ml) >240 minutes Methotrexate (25 mg/ml) >240 minutes Mitomycin C (0.5 mg/ml) >240 minutes Mitoxantrone (2.0 mg/ml)>240 minutes Paclitaxel (Taxol) (6.0 mg/ml) >240 minutes Paraplatin (10 mg/ml)>240 minutes Rituximab (10 mg/ml) >240 minutes Thiotepa (10.0 mg/ml) 22.4 minutes (22.6, 22.4, 23.1) Vincristine Sulfate (1.0 mg/ml) >240 minutes

Warning: Do not use with Carmustine and Thiotepa

Signature Latex Micro

Bleomycin (15 mg/ml) >240 minutes Busulfan (6 mg/ml) >240 minutes Carboplatin (10.0 mg/ml)>240 minutes Carmustine (3.0 mg/ml) 11.4 minutes (12.0, 11.4, 12.5)

Cisplatin (1.0 mg/ml) >240 minutes Cyclophosphamide (Cytoxan) (20 mg/ml) >240 minutes Cytarabine 100 mg/ml >240 minutes Dacarbazine (DTIC) (10.0 mg/ml) >240 minutes Doxorubicin Hydrochloride (2.0 mg/ml) >240 minutes Epirubicin (Ellence) (2 mg/ml) >240 minutes Etoposide (Toposar) (20.0 mg/ml) >240 minutes Fludarabine (25.0 mg/ml)>240 minutes Fluorouracil (50.0 mg/ml)>240 minutes Idarubicin (1.0 mg/ml) >240 minutes Ifosfamide (50.0 mg/ml) >240 minutes Mechlorethamine HCI (1.0 mg.ml)>240 minutes Melphalan (5 mg/ml) >240 minutes Methotrexate (25 mg/ml) >240 minutes Mitomycin C (0.5 mg/ml) >240 minutes Mitoxantrone (2.0 mg/ml) >240 minutes Paclitaxel (Taxol) (6.0 mg/ml) >240 minutes Paraplatin (10 mg/ml) >240 minutes Rituximab (10 mg/ml)>240 minutes Thiotepa (10.0 mg/ml) 12.7 minutes (13.8, 13.1, 12.7) Vincristine Sulfate (1.0 mg/ml) >240 minutes

Warning: Do not use with Carmustine and Thiotepa

Product codes

KGO, LZC

Device Description

Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of

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

0

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

Medline Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093

Re: K202668

Trade/Device Name: Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of 240 minutes Busulfan (6 mg/ml) >240 minutes Carboplatin (10.0 mg/ml) >240 minutes Carmustine (3.0 mg/ml) 12.6 minutes (12.6, 13.1, 12.7) Cisplatin (1.0 mg/ml)>240 minutes Cyclophosphamide (Cytoxan) (20 mg/ml) >240 minutes Cytarabine 100 mg/ml >240 minutes Dacarbazine (DTIC) (10.0 mg/ml) >240 minutes Doxorubicin Hydrochloride (2.0 mg/ml) >240 minutes Epirubicin (Ellence) (2 mg/ml) >240 minutes Etoposide (Toposar) (20.0 mg/ml) >240 minutes Fludarabine (25.0 mg/ml)>240 minutes Fluorouracil (50.0 mg/ml)>240 minutes Idarubicin (1.0 mg/ml) >240 minutes Ifosfamide (50.0 mg/ml) >240 minutes Mechlorethamine HCI (1.0 mg.ml) >240 minutes Melphalan (5 mg/ml) >240 minutes Methotrexate (25 mg/ml) >240 minutes Mitomycin C (0.5 mg/ml) >240 minutes Mitoxantrone (2.0 mg/ml)>240 minutes Paclitaxel (Taxol) (6.0 mg/ml) >240 minutes Paraplatin (10 mg/ml)>240 minutes Rituximab (10 mg/ml) >240 minutes Thiotepa (10.0 mg/ml) 22.4 minutes (22.6, 22.4, 23.1) Vincristine Sulfate (1.0 mg/ml) >240 minutes

Warning: Do not use with Carmustine and Thiotepa

Signature Latex Micro

Bleomycin (15 mg/ml) >240 minutes Busulfan (6 mg/ml) >240 minutes Carboplatin (10.0 mg/ml)>240 minutes Carmustine (3.0 mg/ml) 11.4 minutes (12.0, 11.4, 12.5)

3

Cisplatin (1.0 mg/ml) >240 minutes Cyclophosphamide (Cytoxan) (20 mg/ml) >240 minutes Cytarabine 100 mg/ml >240 minutes Dacarbazine (DTIC) (10.0 mg/ml) >240 minutes Doxorubicin Hydrochloride (2.0 mg/ml) >240 minutes Epirubicin (Ellence) (2 mg/ml) >240 minutes Etoposide (Toposar) (20.0 mg/ml) >240 minutes Fludarabine (25.0 mg/ml)>240 minutes Fluorouracil (50.0 mg/ml)>240 minutes Idarubicin (1.0 mg/ml) >240 minutes Ifosfamide (50.0 mg/ml) >240 minutes Mechlorethamine HCI (1.0 mg.ml)>240 minutes Melphalan (5 mg/ml) >240 minutes Methotrexate (25 mg/ml) >240 minutes Mitomycin C (0.5 mg/ml) >240 minutes Mitoxantrone (2.0 mg/ml) >240 minutes Paclitaxel (Taxol) (6.0 mg/ml) >240 minutes Paraplatin (10 mg/ml) >240 minutes Rituximab (10 mg/ml)>240 minutes Thiotepa (10.0 mg/ml) 12.7 minutes (13.8, 13.1, 12.7) Vincristine Sulfate (1.0 mg/ml) >240 minutes

Warning: Do not use with Carmustine and Thiotepa

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."