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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands to prevent contamination between patient and examiner.

Device Description

The subject device is powder free vinyl synthetic patient examination gloves. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device, "Disposable Vinyl Nitrile Synthetic Gloves Powder Free" (K211516). This document details the device's characteristics and its equivalence to a predicate device, as submitted to the FDA.

Based on the nature of the device (disposable patient examination gloves) and the content of the summary, the "device" in question is not an AI/ML-driven diagnostic or assistive technology. Instead, it is a physical medical device. Therefore, the questions related to AI/ML device performance metrics (such as MRMC studies, standalone algorithm performance, number of experts for ground truth, training set size, etc.) are not applicable to this document.

The acceptance criteria and performance are related to the physical properties, safety, and regulatory compliance of the gloves.

Here's the information that can be extracted from the provided text, related to the device's acceptance criteria and how it meets them:

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

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance	Result
ASTM D5250	Physical Dimensions	Length: ≥230 mm
Width (S): 85±5 mm
Width (M): 95±5 mm
Width (L): 105±5 mm
Width (XL): 115±5 mm
Thickness (Finger): ≥0.08 mm
Thickness (Palm): ≥0.08 mm	Length: >230 mm
Width (S): 88-90 mm
Width (M): 95-97 mm
Width (L): 106-108 mm
Width (XL): 113-116 mm
Finger Thickness: 0.08-0.10 mm
Palm Thickness: 0.09 mm	Pass
ASTM D5151	Watertightness	Meet the requirements of ASTM D5151 AQL 2.5	0/125 leaks	Pass
ASTM D6124	Powder Content	Meet the requirements of ASTM D6124

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K Number

K211262

Device Name

Disposable Vinyl Nitrile Synthetic Gloves Powder Free

Manufacturer

Tangshan Hongyun Healthcare Products Co.,Ltd.

Date Cleared

2021-07-24

(89 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K153028

Intended Use

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands to prevent contamination between patient and examiner.

Device Description

AI/ML Overview

The provided document is a 510(k) summary for a medical device: "Disposable Vinyl Nitrile Synthetic Gloves Powder Free". This document describes the device's characteristics, its comparison to a predicate device, and the results of non-clinical tests conducted to demonstrate its safety and effectiveness.

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

1. Table of Acceptance Criteria and Reported Device Performance

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance
ASTM D5250	Physical Dimensions Test	Length (mm): ≥230
Width (mm): S: 85±5; M: 95±5; L: 105±5; XL: 115±5
Thickness (mm): Finger: ≥0.05, Palm: ≥0.05	Length: >230
Width: S: 84-89; M: 93-97; L: 105-107; XL: 115-116
Finger Thickness: 0.08-0.2
Palm Thickness: 0.07-0.08
Result: Pass
ASTM D5151	Watertightness Test for Detection of Holes	Meet the requirements of ASTM D5151 AQL 2.5	0/125 leaks
Result: Pass
ASTM D6124	Powder Content	Meet the requirements of ASTM D6124

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