# K202668: 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

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Dec 19, 2020 after 96 days
- Product code: KGO (Surgeon'S Gloves)
- Device class: 1
- Regulation: 21 CFR 878.4460
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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 lfosfamide (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 lfosfamide (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

Source page: https://510kreport.com/device/K202668
Methodology: https://510kreport.com/methodology