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, Clear (Non-colored) that meets all of the requirements of ASTM standard D 5250-06.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Device Performance

Characteristics	Standard	Acceptance Criteria	Reported Device Performance
Dimension	ASTM standard D 5250-06	Meets requirements of ASTM standard D 5250-06	Meets
Physical Properties	ASTM standard D 5250-06	Meets requirements of ASTM standard D 5250-06	Meets
Freedom from pinholes	21 CFR 800.20	Meets requirements of 21 CFR 800.20 (and FDA recognition number 2-87 for AQL)	Meets
Powder Amount	ASTM standard D 5250-06 and D6124-06 (and 21 CFR 800.20)	<10 mg/dm² (per ASTM D6124-06)	<10mg/dm²
Biocompatibility: Primary Skin Irritation	Primary Skin Irritation in rabbits (per ANSI / ISO 10993-10:2002)	Not a Primary Skin Irritation	Pass (Not a Primary Skin Irritation)
Biocompatibility: Dermal Sensitization	Dermal sensitization in the guinea pig (per ANSI / ISO 10993-10:2002)	Not a Dermal Sensitization	Pass (Not a Dermal sensitization)

Study Information

Here's the detailed breakdown of the study components based on the provided text:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify the exact sample size for any test set or the data provenance (country of origin, retrospective/prospective). It refers to meeting ASTM and CFR standards, which imply specific testing protocols but don't explicitly state the sample size used in this specific submission's testing.
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)
- This information is not provided in the document. The document describes testing against established standards (ASTM, CFR), not expert-derived ground truth in the context of a clinical or image-based study.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication methods are not applicable here as it's not a study involving human interpretation or subjective assessments that would require adjudication. The testing is based on objective measurements against established 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
- A multi-reader, multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this type of device (patient examination gloves). This device does not involve AI or human interpretation in its function.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- A standalone performance study of an algorithm was not performed, nor is it applicable. This device is a physical medical glove, not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is based on established industry standards and regulatory requirements. This includes:
  - ASTM standard D 5250-06 (for dimensions, physical properties, powder amount)
  - ASTM standard D6124-06 (for powder amount)
  - 21 CFR 800.20 (for freedom from pinholes)
  - FDA recognition number 2-87 for AQL (related to pinholes)
  - ANSI / ISO 10993-10:2002 (for biocompatibility - primary skin irritation and dermal sensitization).
The sample size for the training set
- There is no training set mentioned or implied, as this is a physical product and not an AI/machine learning model.
How the ground truth for the training set was established
- Not applicable, as there is no training set for this device.

Summary

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K091662

Summary

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

"The assigned 510(k) number is: ______________________________________________________________________________________________________________________________________________

JUL 80 2009

Premarket Notification [510(k)] Summary

દ

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Premarket Notinention (on the first page, preferably on your letterhead paper, the ((a)(1)). The summary contains on the first page, preferably on your tetections the submitter states the submitter the summary was prepared : VIJAN PLASTIC PRODUCTS

Submitter's name :	ZHANGJIAGANG FENGYUAN PLASTIC PRODUCTSCO.,LTD
Submitter's address :	Hengjing Village Tangqiao Town Zhang Jia GangJiangsu,215615,China
Phone number :	(86) 512-68416802
Fax number :	(86) 512-68416685
Name of contact person:	Mr. Yu Bang Ting
Date the summary was prepared:	May.26.2009

[(a)(2)]. The name of the device, including the trade or proprietary name if applicable, the contribution in [(a)(2)]. The name of the device, Including the classification name, if known

Device Name:	Powdered Vinyl Patient Examination Gloves, Clear (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

. The success of the substantial equivalence .

Sillstantal varied villant examination gloves, Clear (Non-colored) that meets all of the 11
1 the supported a capaced D 5250-06 Class I' powdered viny pundard D 5250-06.

requirents of ASTASTAL Powdered Vinyl Patient Examination Gloves, Shijiazhuang
Predicate device : FUGUAN (Brand) Powdered Vinyl Patient Examination Gloves, Shijiazhuang
Pre Predicate device : 1 OGGTIF (C. . Fuguan Plastic Products Co., Ltd.. K032907.

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

Device Description : powdered vinyl patient examination gloves, Clear (Non-colored) that meets
(1) = 1) = 1 = 1 = = = = $ ASTM standard D $250-06. Device Description . powdered vary .
all of the requirements of ASTM standard D 5250-06.

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

Device Intended Use: powdered viny] patient examination glove, Clear (Nonis a disposable device intended for medical puposes that is worn on the examiner's and colored) is a disposable device intended for mealor patient and examiner.
hand or finger to prevent contamination between patient and examiner.
Thand or finger to prevent con

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

ell comment predicate device.

promotered virus.
The powdered the following technological characteristics compared to The powdered vinyl patient examination gloves, Clear Nortorers, and of the powered to
are summarized with the following technological characteristics compared to
lare summari ASTM or equivalent standard.

Characteristics	Standard	Device performance
Dimension	ASTM standard D 5250-06	Meets
Physical Properties	ASTM standard D 5250-06	Meets
Freedom from pinholes	21 CFR 800.20	Meets
Powder Amount	ASTM standard D 5250-06and D6124-06	<10mg/dm²
Biocompatability	Primary Skin Irritation in rabbits	PassNot a Primary Skin Irritation
	Dermal sensitization in the guinea pig	PassNot a Dermal sensitization

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

premarket intril patient examination gloves ,Clear (Non-colored) meet requirements per ASTM
Powdered viny CERM D6124.06, per 21 CER 800.20 and FDA recognition number 2-87: AA Powdered vinyl patient examination gloves , Clear (Non-colored) meet requirements per 2017
D5250-06, per ASTM D6124-06, per 21 CFR 800.20 and FDA recognition number 2-87 ANSI / ISO 10993-10:2002.

((b)(2)] A brief discussion of the clinical submitted, reference, or relied on in the premarket

, and the formation for a determination of substantial equivalence . ((b)(2)] A brief discussion of the clinical submitted, volvalence .
notification submission for a determination of substantial equivalence .

Invincal 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 ((b)(3)] The conclusions drawn from the nonclinical and childer than the legally marketed

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

It can be concluded that the Powdered Vinyl Patient Examination Gloves, Clear (Non-colored) It can be concluded that the Powdered Vinyl Patient Examination Cloves, "Search of Concerners for waterleak test on
ment the ASTM standard of equivalent standard and FDA requ pinhole AQL, meet labeling claims .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle with its wings spread, symbolizing protection and strength. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 8 0 2009

Zhang Jia Gang Fengyuan Plastic Products Company, Limited C/O Mr. Chu Xiaoan Official Correspondent Room 1606 Building 1. Jianxiang Yuan No. 209 Bei Si Huan Zhong Road Haidian District Beijing 100083, P.R. China

Re: K091662

Trade/Device Name: Powdered Vinyl patient Examination Gloves Clear (Non-Colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: May 30, 2009 Received: June 9, 2009

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Anthony D. anthon

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Eyaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

Applicant:_ZHANGJIAGANG FENGYUAN PLASTIC PRODUCTS CO.,LTD,

510(k) Number (if known): *

Device Name: Powdered Vinyl Patient Examination Gloves Clear (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 (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)

Shule H. Muyehey Ho

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K091662

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.