Signature Latex LT, 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: K202449
• Device Name: Signature Latex LT, 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: 2020-11-18 ( 84 days)
• Product Code: KGO , LZC
• Regulation Number: 878.4460
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A
• Predicate For: N/A

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.

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a surgical glove, specifically the "Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of 240 minutes (implied) | >240 minutes |
| Busulfan (6 mg/ml) | >240 minutes (implied) | >240 minutes |
| Carboplatin (10.0 mg/ml) | >240 minutes (implied) | >240 minutes |
| Carmustine (3.0 mg/ml) | Not specified as a minimum; result reported | 12.0 minutes (13.2, 12.9, 12.0) |
| Cisplatin (1.0 mg/ml) | >240 minutes (implied) | >240 minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 minutes (implied) | >240 minutes |
| Cytarabine 100 mg/ml | >240 minutes (implied) | >240 minutes |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 minutes (implied) | >240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 minutes (implied) | >240 minutes |
| Epirubicin (Ellence) (2 mg/ml) | >240 minutes (implied) | >240 minutes |
| Etoposide (Toposar) (20.0 mg/ml) | >240 minutes (implied) | >240 minutes |
| Fludarabine (25.0 mg/ml) | >240 minutes (implied) | >240 minutes |
| Fluorouracil (50.0 mg/ml) | >240 minutes (implied) | >240 minutes |
| Idarubicin (1.0 mg/ml) | >240 minutes (implied) | >240 minutes |
| Ifosfamide (50.0 mg/ml) | >240 minutes (implied) | >240 minutes |
| Mechlorethamine HCI (1.0 mg.ml) | >240 minutes (implied) | >240 minutes |
| Melphalan (5 mg/ml) | >240 minutes (implied) | >240 minutes |
| Methotrexate (25 mg/ml) | >240 minutes (implied) | >240 minutes |
| Mitomycin C (0.5 mg/ml) | >240 minutes (implied) | >240 minutes |
| Mitoxantrone (2.0 mg/ml) | >240 minutes (implied) | >240 minutes |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 minutes (implied) | >240 minutes |
| Paraplatin (10 mg/ml) | >240 minutes (implied) | >240 minutes |
| Rituximab (10 mg/ml) | >240 minutes (implied) | >240 minutes |
| Thiotepa (10.0 mg/ml) | Not specified as a minimum; result reported | 22.4 minutes (22.6, 22.4, 23.1) |
| Vincristine Sulfate (1.0 mg/ml) | >240 minutes (implied) | >240 minutes |

Note: For Carmustine and Thiotepa, while specific long resistance times were not achieved, the measured breakthrough times are presented. The "Warning: Do not use with Carmustine and Thiotepa" statement indicates that these drugs did not meet the desired long-duration protection, and this limitation is explicitly communicated in the labeling.

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Non-Applicable Information (due to the nature of the device)

The following points are not applicable to the provided document, as it pertains to a physical medical device (surgical gloves) and not an AI/ML diagnostic or assistive device:

• Sample size used for the test set and the data provenance: The document doesn't specify the exact number of gloves tested for each chemical. The "data provenance" refers to the origin of clinical data, which is not relevant here. The testing is likely done prospectively in a lab setting according to the ASTM standard.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth for chemical permeation is established by standardized laboratory testing methods (ASTM D6978), not by human experts interpreting clinical images or data.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for laboratory testing of physical properties.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: MRMC studies are used for evaluating diagnostic performance of human readers, often with and without AI assistance. This is not relevant for glove permeation testing.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: "Standalone" refers to an AI algorithm's performance. Not applicable here.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for glove performance is the direct measurement of chemical permeation according to the ASTM standard.
• The sample size for the training set: Not applicable. There is no AI/ML algorithm that requires a training set.
• How the ground truth for the training set was established: Not applicable for the same reason.

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).