Powdered 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

powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard I) 525()-00'd

AI/ML Overview

The provided text is for a 510(k) premarket notification for "Powdered Vinyl Patient Examination Gloves, White (Non-colored)." It describes the device, its intended use, and indicates its substantial equivalence to a predicate device. The information focuses on regulatory compliance based on established standards rather than a study proving the device meets acceptance criteria through clinical or comparative effectiveness trials.

Here's a breakdown based on your request, highlighting the information that is not present in the provided document, as it's not typically required for this type of device and submission:

Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (Standard)	Reported Device Performance
Dimension	ASTM standard D 5250-00e4	Meets
Physical Properties	ASTM standard D 5250-00e4	Meets
Freedom from pinholes	21 CFR 800.20	Meets
Powder Amount	ASTM standard D 5250-00e4	Meets
Biocompatibility: Primary Skin Irritation (Rabbits)	Not a Primary Skin Irritation (Implicitly: Passes standard for no irritation)	Passes (<10mg/dm2)
Biocompatibility: Dermal Sensitization (Guinea Pig)	Not a Dermal sensitization (Implicitly: Passes standard for no sensitization)	Passes

Study-Related Information (Not Applicable or Not Provided for this type of device)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. For examination gloves, performance is assessed against established technical standards (ASTM, CFR) through laboratory testing, not human clinical trials with "test sets" in the conventional sense of AI/diagnostic device studies. The document refers to meeting these standards rather than conducting a separate study on a specific "test set" of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. "Ground truth" established by experts is a concept typically relevant to diagnostic devices, especially those using AI. For examination gloves, the "ground truth" is defined by the technical specifications in the ASTM standards and regulatory requirements (e.g., 21 CFR 800.20 for pinholes).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for expert review in clinical studies or AI ground truth establishment, not for laboratory testing of a physical medical device like a glove against predefined technical standards.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, not done, and not applicable. This type of study relates to diagnostic imaging or AI-assisted interpretation, which is entirely outside the scope of an examination glove.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, not done, and not applicable. This applies to AI algorithms.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Standardized laboratory test results against predefined technical specifications. For example, "Freedom from pinholes" is verified by testing against 21 CFR 800.20, and "Biocompatibility" is assessed via standard animal tests (Primary Skin Irritation in rabbits, Dermal Sensitization in guinea pigs) whose results are compared to established criteria for what constitutes irritation/sensitization.
The sample size for the training set:
- Not applicable / Not provided. This device does not involve a "training set" in the context of AI or machine learning. Its manufacturing and testing processes are governed by quality systems and adherence to standards.
How the ground truth for the training set was established:
- Not applicable. As there is no training set for this device type, there is no ground truth to be established for it.

Summary

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C Summary

AUG 1 6 2005

"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."

"The assigned 510(k) number is: _ (25) 923 ." (applicant leave blank)

Premarket Notification [510(k)] Summary

1(a)(1)). The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared :

Submitter's name :	SHIJIAZHUANG WONDER PLASTIC CO.,LTD
Submitter's address :	NO.6 TONGDA ROAD, JINZHOU CITY, HEBEI 052260
Phone number :	(86) 311-4320507
Fax number :	(86) 311-4320507
Name of contact person:	Ms. Wang Jiawei
Date the summary was prepared:	26 April 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	Powdered Vinyl Patient Examination Gloves,White (Non-colored)
Proprietary/Trade name:	Powdered 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* powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4

Predicate device : FUGUAN (Brand) Powdered Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032907.

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

Device Description : powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard I) 525()-00'd

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

Device Intended Use: powdered vinyl patient examination glove shire(nomecolored) 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 powdered vinyl patient examination gloves, white (non-colored) non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.

Characteristics	Standard	Device performance
Dimension	ASTM standard D 5250-00e4	Meets
Physical Properties	ASTM standard D 5250-00e4	Meets
Freedom from pinholes	21 CFR 800.20	Meets
Powder Amount	ASTM standard D 5250-00e4	Meets
Biocompatability	Primary Skin Irritation in rabbits	<10mg/dm2Passes
	Dermal sensitization in the guinea pig	Not a Primary Skin IrritationPasses
		Not a Dermal sensitization

((b)(1) A_brief discussion of the nonctinical submitted, reference, or relied on in the premarket notification submission for a deternination of substantial equivalence .

Powdered vinyl patient examination gloves ↓ white(non-colored) meet requirements per ASTM D5250-00'd, per ASTM D6124-01, per 21 CFR 800.20 and 1501099-10.

((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, and performed as well or better than the legally narketed device identified in (a)(3).

It can be concluded that the Powdered Vinyl Patient Examination Gloves. White(non-colored) meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL, meet labeling claims .

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AUG 1 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shijiazhuang Wonder Plastic Company, Incorporated C/O Chu Xiaoan Rm 1606 Bldg. 1. Jianxiangyuan No. 209 Bei Si Huan Zhong Rd. Haidian District Beijing CHINA 100083

Re: K051923

Trade/Device Name: Powdered 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

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,

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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3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The information, data and labeling claims in the entire 510(k) submission must support and agree with the Indications for Use statement.

INDICATIONS FOR USE

Applicant: SHIJIAZHUANG WONDER PLASTIC CO., LTD

510(k) Number (if known):_* 七〇〇〇〇〇

Device Name: _ Powdered Vinyl Patient Examination Gloves, White(Non-colored)

Indications For Use:

Powdered 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)

AND/OR

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

(Please do not WRITE BELOW THIS LINE-CONTINUE on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

nesthesiology, General Hospital. Control I

510(k) Number: K051923

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.