Powder free vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

powder free vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4

AI/ML Overview

The provided K051935 Premarket Notification [510(k)] Summary pertains to "Powder Free Vinyl Patient Examination Gloves, White (non-colored)". This device is a medical glove, and the acceptance criteria and study detailed are for demonstrating its compliance with relevant standards and safety.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristics	Acceptance Criteria (Standard)	Reported Device Performance
Dimension	ASTM standard D 5250-00c4	Meets
Physical Properties	ASTM standard D 5250-00c4	Meets
Freedom from pinholes	21 CFR 800.20	Meets
Powder Residual	ASTM standard D 5250-00c4 and D6124-01	<2mg/glove
Biocompatibility	Primary Skin Irritation in rabbits	Passes (Not a Primary Skin Irritation)
	Dermal sensitization in the guinea pig	Passes (Not a Dermal Sensitization)

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the specific sample sizes used for each test (Dimension, Physical Properties, Freedom from pinholes, Powder Residual, Biocompatibility). It refers to meeting the requirements of the standards (ASTM D 5250-00c4, 21 CFR 800.20, D6124-01, and ISO10993-10). These standards would define the required sample sizes for such testing.

The data provenance is not explicitly stated as retrospective or prospective, nor does it mention a specific country of origin for the data (beyond the submitter's address being in China). However, generally, performance testing for medical devices like gloves is conducted prospectively on manufactured samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not applicable in the context of this device and its testing. Performance criteria for medical gloves are based on established engineering and safety standards (e.g., ASTM, FDA regulations). There is no "ground truth" established by human experts in the same way it would be for an AI diagnostic device. The "ground truth" is defined by the objective measurements and pass/fail criteria of the specified standards.

4. Adjudication Method for the Test Set:

This information is not applicable. As mentioned above, the tests are objective measurements against established standards, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for diagnostic devices where human readers interpret data (e.g., medical images) with and without AI assistance to assess the AI's impact on human performance. For a patient examination glove, such a study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone study was not done. This concept is also primarily applicable to diagnostic algorithms. The "device" in this case is a physical product (gloves) whose performance is assessed through laboratory testing against physical, chemical, and biological standards, not through an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" used for this device is based on established objective criteria defined within recognized standards and regulations. These include:

ASTM standard D 5250-00c4: Specifies requirements for dimensions, physical properties, and powder residue.
21 CFR 800.20: Relates to freedom from pinholes (waterleak test AQL).
ASTM D6124-01: Also concerns powder residue.
ISO10993-10: Addresses biocompatibility (primary skin irritation and dermal sensitization).

Essentially, the ground truth is the compliance with these pre-defined, measurable specifications.

8. The Sample Size for the Training Set:

This device does not have a "training set" in the typical sense of machine learning or AI. Performance testing is done on manufactured samples according to the specifications of the referenced standards. There is no algorithm being "trained."

9. How the Ground Truth for the Training Set Was Established:

As there is no training set, this question is not applicable.

Summary

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K051935

Premarket Notification [510(k)] Summary

[(a)(1)]. The summary contains on the first page, preferably on your letterhead paper, thesubmitter's name, address, phone and fax numbers, name of contact person, and date thesummary was prepared :
Submitter's name :	SHIJIAZHUANG WONDER PLASTIC CO.,LTD
Submitter's address :	NO.6 TONGDA ROAD,JINZHOU CITY, HEBEI, 052260, P.R.CHINA
Phone number :	(86) 311-4320507
Fax number :	(86) 311-4320507
Name of contact person:	Ms. Wang Jiawei
Date the summary was prepared:	26 June 2005

[(a)(2)]. The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known

Device Name:	Powder Free Vinyl Patient Examination Gloves, white(non-colored)
Proprietary/Trade name:	Powder Free Vinyl Patient Examination GlovesOther clients private labeling
Common Name:	Patient examination glove
Classification Name:	Patient examination glove
Device Classification:	I
Regulation Number:	21 CFR 880.6250
Panel:	General Hospital (80)
Product Code:	LYZ

[(a)(3)]. An identification of the legally marketed device to which your firm is claiming substantial equivalence .

Class I* powder free vinyl patient examination gloves , white(non-colored) that meets all of the requirements of ASTM standard D 5250-0014.

Predicate device : FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032908 .

[(a)(4)] A description of the device

Device Description : powder free vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4

Page 1of 2 Section C

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[(a)(5)] The summary describes the intended use of the device

Device Intended Use: powder free vinyl patient examination glove, white(non-colored) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

[(a)(6)] A summary of the technological characteristics of new device compared to the predicate device.

The powder free vinyl patient examination gloves, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.

Characteristics	Standard	Device performance
Dimension	ASTM standard D 5250-00c4	Meets
Physical Properties	ASTM standard D 5250-00c4	Meets
Freedom from pinholes	21 CFR 800.20	Meets
Powder Residual	ASTM standard D 5250-00c4	Meets
	and D6124-01	<2mg/glove
Biocompatability	Primary Skin Irritation inrabbits	Passes
		Not a Primary Skin Irritation
	Dermal sensitization in theguinea pig	Passes
		Not a Dermal sensitization

[(b)(1)] A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .

Powder free vinyl patient examination gloves , white(non-colored) meet requirements per ASTM D5250-0064, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10.

[(b)(2)] A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .

Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

[(b)(3)] The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe,as effective, and performed as well or better than the legally marketed device identified in (a)(3).

It can be concluded that the Powder Free Vinyl Patient Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims .

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the snake and staff. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shijiazhuang Wonder Plastic Company Limited C/O Mr. Chu Xiaoan Rm. 1606, Building 1, Jianxiangyuan No. 209 Bei Si Huan Zhong Road Haidian District Beijing, CHINA 100083

Re: K051935

Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, White (non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: June 26, 2005 Received: July 15, 2005

AUG 2 - 2005

Dear Mr. Xiaoan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device. subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Xiaoan

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clerk

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K051935

Device Name: Powder Free Vinyl Patient Examination Gloves, White (noncolored)

Indications For Use:

Powder free vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D)

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AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shirl W. Murphy, MD 8/2/05

510(k) Number. K051935

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Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.