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, 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 study information for the "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)" based on the provided document:

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 (waterleak test on pinhole AQL)
Powder Residual	ASTM standard D 5250-06 and D6124-06	<2mg/glove
Biocompatibility:
- Primary Skin Irritation	Primary Skin Irritation in rabbits (ISO10993-10)	Passes (Not a Primary Skin Irritation)
- Dermal Sensitization	Dermal sensitization in the guinea pig (ISO10993-10)	Passes (Not a Dermal sensitization)

Study Details

The provided document describes a premarket notification for a Class I medical device (patient examination gloves). For such devices, extensive clinical studies are generally not required. The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, K032908) by meeting established industry standards and regulatory requirements.

Here's an analysis of the requested information based on the document:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document does not explicitly state the specific sample sizes used for each test (e.g., how many gloves were tested for pinholes, or how many animals were used for biocompatibility). It references adherence to the standards (ASTM D5250-06, ASTM D6124-06, 21 CFR 800.20, ISO10993-10), which would define the required sample sizes for each test.
Data Provenance: The manufacturing company is TANGSHAN CHANGRONG GLOVE CO., LTD. in China. The testing was conducted to ASTM and ISO standards, which are internationally recognized. The document doesn't explicitly state the country of origin of the data itself beyond the manufacturer's location. The studies are retrospective in the sense that they are conducted on finished product batches to ensure compliance with standards, rather than a prospective clinical trial.

3. 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)

Number of Experts & Qualifications: Not applicable in the context of this device. The "ground truth" for these tests is defined by the objective pass/fail criteria of the specified ASTM, ISO, and FDA standards themselves (e.g., a hole is present or not, weight is above/below a threshold, a biological response is observed or not). These are physical and chemical tests, not interpretations by medical experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. The tests are objective and based on established measurement methods and criteria within the referenced standards. There is no subjective interpretation or need for expert consensus adjudication for these types of physical, chemical, and biological safety tests.

5. 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

MRMC Study: No. This type of study is completely irrelevant for patient examination gloves. MRMC studies are typically used for evaluating diagnostic imaging algorithms where human readers interpret medical images.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. This device is a physical product (gloves), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: The ground truth is based on objective measurements against established scientific and regulatory standards. For example:
- Dimension: Measured physical dimensions compared to ASTM D5250-06 specified ranges.
- Physical Properties: Tensile strength, elongation at break, etc., measured according to ASTM D5250-06.
- Freedom from pinholes: Water leak test (21 CFR 800.20), where the presence or absence of a water leak constitutes the ground truth.
- Powder Residual: Gravimetric analysis to determine powder weight, compared to the <2mg/glove threshold.
- Biocompatibility: Observation of specific biological reactions (irritation, sensitization) in animal models as defined by ISO10993-10 protocols.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is a physical product, not an AI/ML algorithm that requires a "training set." The manufacturing process itself (Good Manufacturing Practices) and quality control over successive production batches ensure consistency, rather than a data training process.

9. How the ground truth for the training set was established

How Ground Truth for Training Set was Established: Not applicable, as there is no training set mentioned or relevant for this device.

Summary

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Summary

K100339

"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: ______________________________________________________________________________________________________________________________________________

Premarket Notification [510(k)] Summary

MAR 2 2 2010

[(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 :	TANGSHAN CHANGRONG GLOVE CO., LTD.
Submitter's address :	MIGUANYING, LUANNAN COUNTY, TANGSHAN CITY,HEBEI PROVINCE, 063500, CHINA
Phone number :	(86) 315-4169201
Fax number :	(86) 315-4169311
Name of contact person:	Mr. Zhang Liang
Date the summary was prepared:	Jan. 10th, 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, Clear(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 , Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

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, Clear(non-colored) 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, Clear(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 5250-06	Meets
Physical Properties	ASTM standard D 5250-06	Meets
Freedom from pinholes	21 CFR 800.20	Meets
Powder Residual	ASTM standard D 5250-06and D6124-06	<2mg/glove
Biocompatability	Primary Skin Irritation inrabbits	PassesNot a Primary Skin Irritation
	Dermal sensitization in theguinea pig	PassesNot 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 , Clear(non-colored) meet requirements per ASTM D5250-06, per ASTM D6124-06, 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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

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

Mr. Chu Xiaoan Official Correspondent Tangshan Changrong Glove Company, Limited Room 1606 Building . 1. Jianxiang Yuan, No 209 Bei Si Huan Zho Beijing, China 100083

MAR 2 2 2010

Re: K100339

Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, Clear (Non- Colored) Regulation Number: 21CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: January 10, 2010 Received: February 5, 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 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/AboutlFDA/CentersOffices/CDRH/CDRHOffices/ ucm 1 15809.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,

Susan Ruarer

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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K100339

INDICATIONS FOR USE

Applicant: TANGSHAN CHANGRONG GLOVE CO.,LTD.

510(k) Number (if known): *

Device Name: _ Powder Free Vinyl Patient Examination Gloves, Clear(Non-colored)

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)

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

510(k) Number: K100339

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.