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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The SafeSource Direct Blue Powder-Free Nitrile Exam Gloves are a patient examination glove that is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs. The purpose of this submission is to add two additional sizes (AMERI-TUFF Series 4000 XS and XXL) and additional series (AMERI-TOUCH Series 5000 XS through XXL) of SafeSource Direct Blue Powder-Free Nitrile Exam Glove

This document is a 510(k) Summary for a medical device (SafeSource Direct Blue Powder-Free Nitrile Exam Gloves) seeking FDA clearance. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data (i.e., laboratory testing). It does not involve a study of an AI-powered device or a human-in-the-loop performance study.

Therefore, many of the requested elements related to AI/MRMC studies, expert ground truth adjudication, and training/test set details for AI models are not applicable to this document. I will focus on the acceptance criteria and the study that proves the device meets those criteria, as detailed in the provided text.

Here's a breakdown based on the information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The device under review includes two series of gloves: AMERI-TUFF Series 4000 and AMERI-TOUCH Series 5000. Not all tests explicitly differentiate between the series in the summary table, but chemotherapy permeation times are distinct.

Width (mm):
XS: 70 ± 10
S: 80 ± 10
M: 95 ± 10
L: 110 ± 10
XL: 120 ± 10
XXL: 130 ± 10

Thickness (mm):
Finger: ≥ 0.05
Palm: ≥ 0.05 | Length (mm):
XS/S: ≥ 220 / Pass
M/L/XL/XXL: ≥ 230 / Pass

Width (mm):
XS: 70 ± 10 / Pass
S: 80 ± 10 / Pass
M: 95 ± 10 / Pass
L: 110 ± 10 / Pass
XL: 120 ± 10 / Pass
XXL: 130 ± 10 / Pass

Thickness (mm):
Finger: 0.05 / Pass
Palm: 0.05 / Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | Complies with ASTM D6319-19 and ASTM D5151-06 (Though the table specifically lists "Complies with ASTM D6319-19 and ASTM D5151-06", the stated acceptance criteria for D5151 is AQL 2.5, implying the result also meets this). |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Carmustine (BCNU) 3.3 mg/ml 35.8 Minutes
Cisplatin 1.0 mg/ml ≥ 240 Minutes
Cyclophosphamide (Cytoxan) 20.0 mg/ml ≥ 240 Minutes
Dacarbazine (DTIC) 10.0 mg/ml ≥ 240 Minutes
Doxorubicin Hydrochloride 2.0 mg/ml ≥ 240 Minutes
Etoposide (Toposar) 20.0 mg/ml ≥ 240 Minutes
Fluorouracil 50.0 mg/ml 0.5 mg/ml ≥ 240 Minutes
Methotrexate 25 mg/ml ≥ 240 Minutes
Mitomycin C 0.5 mg/ml ≥ 240 Minutes
Paclitaxel (Taxol) 6.0 mg/ml ≥ 240 Minutes
Thio-Tepa 10.0 mg/ml 87.0 Minutes
Vincristine Sulfate (Oncovin) 1.0 mg/ml ≥ 240 Minutes

Please note that the following drugs have low permeation times:
Carmustine (BCNU) 3.3 mg/ml 35.8 Minutes
Thio-Tepa 10.0 mg/ml 87.0 Minutes
Not recommended for use with these drugs.

The SafeSource Direct Blue Powder-Free Nitrile Exam Gloves are a patient examination glove that is a non-sterile, single use, disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs. These gloves are made of synthetic copolymer of acrylonitrile and butadiene (NBR rubber) with a blue dye. The gloves are available in small, medium, large, and extra-large.

The provided document is a 510(k) Premarket Notification for SafeSource Direct Blue Powder-Free Nitrile Exam Gloves. It details the acceptance criteria and performance data for this medical device, which is a non-powdered patient examination glove.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

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The SafeSource Direct Procedure Mask with Ear Loops is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, bodily fluids, and particulate material. These procedure masks are intended for use in infection control practices to reduce to blood and bodily fluid. The procedure masks are single use, disposable devices, provided non-sterile.

The SafeSource Direct Surgical Mask with Ties is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, bodly fluids, and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and bodily fluid. The surgical masks are single use, disposable devices, provided non-sterile.

The Procedure Mask with Ear Loops (PM3001, PM3003) is a non-sterile, single use, three-layer, flat-folded mask with ear loops, and a nose wire. The Procedure Mask with Ear Loops is constructed of inner and outer layers consisting of spunbond polypropylene and a middle layer of meltblown polypropylene. The welded ear loops made of spandex/elastane fiber and polyester filament keep the user's mouth and nose. The ethylene propylene copolymer coated aluminum nose wire allows the user to fit the mask around their nose.

The Surgical Mask with Ties (SM3001, SM3003) is a non-sterile, single use, three-layer, flat-folded mask with ties, and a nose wire. The Surgical Mask with Ties is constructed of inner and outer layers consisting of spunbond polypropylene and a middle layer of meltblown polypropylene. The welded polypropylene tie straps keep the mask close to the user's mouth and nose. The ethylene propylene coated aluminum nose wire allows the user to fit the mask around their nose.

This document describes the performance of a medical device, specifically Procedure Masks with Ear Loops and Surgical Masks with Ties, submitted for FDA 510(k) clearance (K221134). The device is compared to a predicate device (K202899) to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are based on ASTM F2100-19 for medical face mask performance, and other relevant standards like ASTM F1862/F1862M-17 (Fluid Resistance), ASTM F2299/F2299M-03 (Particulate Filtration Efficiency), ASTM F2101-19 (Bacterial Filtration Efficiency), EN 14683:2019 + AC:2019 Annex C (Differential Pressure), 16 CFR 1610 (Flammability), ISO 10993-5: 2009 (Cytotoxicity), and ISO 10993-10: 2010 (Irritation and Sensitization).

There are two tables provided in the document:

• Table 1: Comparison of Performance Testing for Proposed ASTM Level 1 Procedure Mask with Ear Loops (PM3001) and Surgical Mask with Ties (SM3001) with Predicate Device
• Table 2: Comparison of Performance Testing for Proposed ASTM Level 3 Procedure Mask with Ear Loops (PM3003) and Surgical Mask with Ties (SM3003) with Predicate Device

Table 1: ASTM Level 1 Masks (PM3001 & SM3001)

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