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, Colored (White) 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	Acceptance Criteria (Standard)	Reported 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 Residual	ASTM standard D 5250-06 and D6124-06	<2mg/glove
Biocompatibility (Primary Skin Irritation)	Primary Skin Irritation in rabbits	Passes (Not a Primary Skin Irritation)
Biocompatibility (Dermal Sensitization)	Dermal sensitization in the guinea pig	Passes (Not a Dermal Sensitization)

Study Information

The provided document describes a premarket notification for a medical device (Powder Free Vinyl Patient Examination Gloves, Colored (White)) and focuses on demonstrating substantial equivalence to a predicate device. It primarily relies on non-clinical testing to meet the acceptance criteria.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for specific tests. The document indicates that the device "meets requirements per ASTM D5250-06, per ASTM D6124-06, per 21 CFR 800.20 and ISO10993-10." These standards inherently require specific sample sizes for their respective tests, but the exact numbers used in this specific submission are not detailed.
- Data Provenance: The manufacturing company is based in China: Hebei Handform Plastic Products Co.,Ltd., Julu County industrial park, Xingtai, Hebei Province, 055250, CHINA. It can be inferred that the testing was conducted to demonstrate compliance with these international standards, but the specific location of the testing laboratories is not specified. The study is prospective in the sense that these tests were conducted to demonstrate the device's properties before market entry for regulatory approval.
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 question is not applicable to this type of device and study. The "ground truth" for glove performance is established by objective measurements and adherence to recognized standards (ASTM, CFR, ISO) rather than expert consensus on subjective interpretations like in imaging studies.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable to this type of device and study. Adjudication methods are typically used in clinical trials involving subjective endpoints or complex interpretations, not for objective material property testing.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving human interpretation of data, often with AI assistance. This device is a patient examination glove, so such a study would not be applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device does not involve an algorithm. The "performance" here refers to the physical and biocompatibility characteristics of the glove itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device is based on objective measurements against established international and regulatory standards for material properties, dimensions, physical characteristics, freedom from defects, powder residue, and biocompatibility. These standards are themselves the "truth" against which the device's performance is measured.
  - 21 CFR 800.20: Freedom from pinholes (water leak test)
  - ASTM D 5250-06: Dimensions, Physical Properties
  - ASTM D6124-06: Powder Residual
  - ISO10993-10: Biocompatibility (Primary Skin Irritation and Dermal Sensitization)
The sample size for the training set
- This question is not applicable. This device is not an AI/ML algorithm that requires a "training set." The product is a physical medical device (examination gloves).
How the ground truth for the training set was established
- This question is not applicable, as there is no training set for this device.

Summary

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Summary

"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: K101358 " (applicant leave blank)

Premarket Notification [510(k)] Summary

[(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 :	Hebei Handform Plastic Products Co.,Ltd.
Submitter's address :	Julu County industrial park, Xingtai, Hebei Province,055250, CHINA
Phone number :	(86) 319-4361966
Fax number :	(86) 319-4362371
Name of contact person:	Mr. LIU Wei
Date the summary was prepared:	Apr. 29th. 2010

[(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, Colored(White)
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, Colored (White) that meets all of the requirements of ASTM standard D 5250-06.

Predicate device : Powder-Free Vinyl Patient Examination Gloves,. SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., LTD.,K051156 .

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

Device Description : powder free vinyl patient examination gloves, Colored (White) that meets 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: powder free vinyl patient examination glove, Colored (White) 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 5250-06	Meets
Physical Properties	ASTM standard D 5250-06	Meets
Freedom from pinholes	21 CFR 800.20	Meets
Powder Residual	ASTM standard D 5250-06	Meets
	and D6124-06	<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 non-clinical testing data that was submitted, referenced or relied on to demonstrate that the Subject Device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses.

Powder free vinyl patient examination gloves , Colored (White) meet requirements per ASTM D5250-06, per ASTM D6124-06, per 21 CFR 800.20 and ISO10993-10. , it is safe and effective, and it's performance meets the requirements of its pre-defined acceptance criteria and intended uses.

[(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 . It is as safe, as effective, and performed as well the legally marketed device identified in (a)(3).

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Image /page/2/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized eagle emblem, consisting of three curved lines that form the body and wings of the eagle. The eagle is facing to the right.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Hebei Handform Plastic Products Company, Limited C/O Mr. Chu Xiaoan Room 1606 Building 1 Jianxiang Yuan No 209 Bei Si Beijing China 100083

AUG 2 4 2010

Re: K101358

Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, Colored (White) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: August 12, 2010 Received: August 16, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 Eederal 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Susa Quares

Anthony D. Watson, B.S., M.S., M.B.A. 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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K101358

INDICATIONS FOR USE

Applicant: Hebei Handform Plastic Products Co.,Ltd.

510(k) Number (if known): * 101358

Device Name ._ Powder Free Vinyl Patient Examination Gloves, Colored (White)

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) 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)

Elaine Mayhall for Elizabeth Clareine

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

510(k) Number: K161358

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.