Nitrile Powder Free Patient Examination Gloves, Coloured (Blue) 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

Nitrile Powder Free Patient Examination Gloves that meets all of the requirements of ASTM standard D 6139-05

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Nitrile Powder Free Patient Examination Gloves.

It's important to note that this document is a 510(k) summary for a Class I medical device (gloves). For such devices, clinical studies are typically not required, and the focus is on meeting established performance standards (ASTM, FDA regulations). Therefore, many of the typical AI/software device evaluation criteria (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies) are not applicable or present in this submission.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Standard	Reported Device Performance
Dimension	ASTM standard D 6139-05	Meets
Physical Properties	ASTM standard D 6139-05	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:	ISO10993-10
- Primary Skin Irritation	In rabbits	Passes (Not a Primary Skin Irritation)
- Dermal Sensitization	In the guinea pig	Passes (Not a Dermal sensitization)

Study Information

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 explicit sample sizes for the individual tests (Dimension, Physical Properties, Freedom from pinholes, Powder Residual, Biocompatibility). These are typically quality control tests performed on batches of gloves according to the relevant ASTM or ISO standards.
- Data provenance is not explicitly stated, but given the manufacturer is based in China, it is highly likely the testing was conducted there. The testing is prospective in the sense that it evaluates the manufactured product against predefined standards.
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 criterion is not applicable. The "ground truth" for glove performance involves objective measurements and adherence to specified physical and chemical properties defined by standards (ASTM, ISO, CFR). It does not rely on expert interpretation in the same way clinical diagnostic devices do. Biocompatibility tests are conducted by specialized laboratories.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Performance is determined by objective measurements against numerical or qualitative pass/fail criteria defined in the standards, not by expert adjudication.
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
- Not applicable. This device is a physical examination glove, not an AI-powered diagnostic tool. MRMC studies are not relevant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical product, not an algorithm or software.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is based on objective measurements against established engineering and material science standards (ASTM D6139-05, ASTM D5250-06, ASTM D6124-06, 21 CFR 800.20, ISO10993-10). This includes dimensional accuracy, physical strength, integrity (freedom from pinholes), chemical residue, and biological reaction (irritation, sensitization).
The sample size for the training set
- Not applicable. This concept pertains to machine learning models, which are not relevant for this device.
How the ground truth for the training set was established
- Not applicable, as there is no training set in the context of this device.

Summary of the Study:

The "study" demonstrating the device meets acceptance criteria is primarily a series of non-clinical bench and lab tests against well-established international and national standards. The manufacturer conducted these tests and reported that their Nitrile Powder Free Patient Examination Gloves "Meets" or "Passes" all specified criteria from ASTM D 6139-05, 21 CFR 800.20, ASTM D 5250-06, ASTM D6124-06, and ISO10993-10. These tests cover the critical performance aspects for patient examination gloves, including their physical integrity, durability, and biocompatibility, ensuring they are safe and effective for their intended medical purpose of preventing contamination. No clinical data was required or submitted, as is typical for this type of 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: K110185 " (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 :	TANGSHAN BAOJIE GLOVE CO.,LTD.
Submitter's address :	PACHIGANG INDUSTRIAL ZONE,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. 5th, 2011

[(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:	Nitrile Powder Free Patient Examination Gloves, Coloured(Blue)
Proprietary/Trade name:	Nitrile Powder Free Patient Examination Gloves, Coloured(Blue)
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:	LZA

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

Class I* Nitrile Powder Free Patient Examination Gloves that meets all of the requirements of ASTM standard D 6139-05

Predicate device : Nitrile powder-free patient examination glove, JDA International Inc. K993247 .

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

Device Description : Nitrile Powder Free Patient Examination Gloves that meets all of the requirements of ASTM standard D 6139-05

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K110185

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

Device Intended Use: Nitrile Powder Free Patient Examination Gloves 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 6139-05	Meets
Physical Properties	ASTM standard D 6139-05	Meets
Freedom from pinholes	21 CFR 800.20	Meets
Powder Residual	ASTM standard D 5250-06	Meets
Biocompatability	and D6124-06	<2mg/glove
	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 .

Nitrile powder-free patient examination glove meet requirements per ASTM D6319-05, 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 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 Nitrile powder-free patient examination glove 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 features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.

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

Mr. Chu Xiaoan Tangshan Baojie Glove Company, Limited Room 1606 Building 1. Jianxiang Yuan No 209 Bei Si Beijing China 100083

APR - 4 2011

Re: K110185

Trade/Device Name: Nitrile Powder Free Patient Examination Gloves, Colored (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: January 21, 2011 Received: January 21, 2011

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/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 CDRF'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,
dams titoson
for 2

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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INDICATIONS FOR USE

Applicant: TANGSHAN BAOJIE GLOVE CO.,LTD.

510(k) Number (if known): * K | | 0 | 85

Device Name: Nitrile Powder Free Patient Examination Gloves, Coloured (Blue)

Indications For Use:

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)

Elizabeth F. Cluverius Wills

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

85 510(k) Number

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.