A Vinyl patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

Class I vinyl patient examination gloves 80LYZ,powdered,that meets all the requirements of ASTM D 5250-00.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "Vinyl Examination Gloves, Powdered." This is a medical device submission, but it outlines the equivalence of the gloves to a legally marketed predicate device rather than detailing an AI/ML-based diagnostic system. As such, many of the requested categories (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone algorithm performance, and ground truth establishment for AI) are not applicable to this type of submission for a physical medical device like gloves.

However, I can extract the acceptance criteria and how the device (gloves) is shown to meet them based on the information provided.

Acceptance Criteria and Device Performance (Vinyl Examination Gloves)

This submission focuses on demonstrating substantial equivalence to a predicate device, specifically "Class I vinyl patient examination gloves 80LYZ, powdered, that meets all the requirements of ASTM D 5250-00." The acceptance criteria for the new device are directly linked to meeting the requirements of this ASTM standard and other specified tests.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance/How it's Met
Material Equivalence	Chemical composition of the glove material.	Listed chemical components (PVC resin, DOP, TXIB, Epoxidized Soyabean Oil, Ca/Zn carboxylate stabilizer) are presumably equivalent to those used in the predicate device meeting ASTM D 5250-00. Details are not provided in the summary but are implied to be part of the full submission.
Physical Properties	Size specifications and various physical properties as defined by ASTM D 5250-00.	"Please refer to attached sheet.(SPECIFICATION OF POWDERED VINYL EXAMINATION GLOVFS, APRIL 30, 2002)" This indicates that the device meets the physical property requirements of ASTM D 5250-00, which includes tensile strength, elongation, and dimensions.
Barrier Integrity (Pin Hole)	FDA 1000ml water leak test, with specific sampling procedure and acceptance quality level (AQL).	The device is subjected to the "FDA 1000ml water leak test" with a specified sampling procedure and AQL. The implication is that the device passes this test to the required AQL, demonstrating barrier integrity equivalent to the predicate.
Classification	Meet Class I vinyl patient examination gloves 80LYZ as per regulatory classification.	The device is identified as "Class I vinyl patient examination gloves 80LYZ, powdered," matching the classification of the predicate device.

Regarding the study that proves the device meets the acceptance criteria:

The study proving the device meets the acceptance criteria is primarily a bench-testing and materials characterization study, as is typical for non-software/AI medical devices like examination gloves. The submission is a demonstration of substantial equivalence to an existing predicate device based on adherence to recognized standards.

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

Test Set Sample Size: The document explicitly mentions "Sampling procedure and acceptance quality level" for the Pin Hole test. While the exact number of gloves tested is not provided in this summary, it would be determined by the specific "sampling procedure" and "acceptance quality level" (AQL) outlined for the FDA 1000ml water leak test. These AQL tables specify the sample sizes required to make an inference about the quality of a lot.
Data Provenance: The studies were conducted by "TANGSHAN ZHONGHONG PULIN FOOD PRODUCTS CO.,LTD." which is located in "LUANNAN, TANGSHAN CITY, HEBEI PROVINCE, CHINA." This indicates the data originated from China, likely from internal company testing. The data would be prospective in the sense that the manufacturer tested their produced gloves to ensure they meet the standards.

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)

Not Applicable. For a physical product like examination gloves, "experts" in the sense of clinical specialists establishing a "ground truth" for diagnostic accuracy are not relevant. The "ground truth" here is adherence to specified physical and material properties, which are measured objectively using standardized laboratory tests by qualified quality control personnel.

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

Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in expert interpretations, particularly in diagnostic imaging or clinical trials. For objective physical and chemical tests (e.g., measuring tensile strength, performing a water leak test), the results are quantitative and do not typically require expert adjudication in this manner. Standard laboratory practices for quality control and verification would be followed.

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

Not Applicable. This is a physical product (gloves), not an AI/ML diagnostic device. MRMC studies are used for evaluating physician performance with and without AI assistance for diagnostic tasks.

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

Not Applicable. This is a physical product (gloves), not an AI algorithm.

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

The "ground truth" for these gloves is defined by the objective, measurable standards outlined in ASTM D 5250-00 (e.g., specific values for tensile strength, elongation, dimensions) and the performance criteria for the FDA 1000ml water leak test (e.g., maximum allowed pinholes per sample size). It relies on standardized test methods and predefined quantitative thresholds, not expert consensus or pathology in a clinical sense.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device that requires a training set.

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

Not Applicable. This is not an AI/ML device that requires a training set.

Summary

{0}------------------------------------------------

TANGSHAN ZHONGHONG PULIN FOOD PRODUCTS CO.,LTD.

LUANNAN,TANGSHAN CITY,HEBEI PROVINCE,CHINA

Tcl: 86-315-4168379 Fax: 86-315-4168700

KO 22336

510 (k) SUMMARY

OCT 1 1 2002

Submitter's name and address:

Baldur Systems Corporation

33235 Transit Avenue

Union City,CA 94587

Telephone and Fax numbers of submitter:

Tel:510-477-9194

Fax:510-477-9634

David Hu,Ph.d.,president Contact person:

l)ate summary prepared: April 30,2002

1. Common name: Exam gloves
  Classification name: Patient examination glove
1. Legally marketed device:
  Class I vinyl patient examination gloves

80LYZ,powdered,that meets all the requirements

of ASTM D 5250-00.

1. Description of the device:
  Class I vinyl patient examination gloves 80LYZ,powdered,that meets all the requirements of ASTM D 5250-00.

{1}------------------------------------------------

TANGSHAN ZHONGHONG PULIN FOOD PRODUCTS CO.,LTD. LUANNAN,TANGSHAN CITY,HEBEI PROVINCE,CHINA Tcl: 86-315-4168379 Fax: 86-315-4168700

EQUIVALENCE CLAIM

We claim that our gloves are equivalent to class I vinyl examination glove, product code 80LYZ,powdered,that meet all the requirements of ASTM standard D5250-00. For details please see bclow:

l ) Chemical data

Name of chemicals:

PVC resin

DOP(di-octyl-phthalate)

TXIB(2,2,4 trimthyl ,1,3 pentanediol,diisobutylate)

Epoxidized Soyabean Oil

Ca/Zn carboxylate stabilizer

2)Size specification and physical properties.

Please refer to attached sheet.(SPECIFICATION OF POWDERED

VINYL EXAMINATION GLOVFS,APRIL 30,2002)

Pin Holc

3.1 Test method: use FDA 1000ml water leak test.

3.2 Sampling procedure and acceptance quality level.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tangshan Zhonghong Pulin Food Products Company Limited C/O Mr. David Hu President HTI Trading Group 33235 Transit Avenue Union City, California 94587

OCT 11 2002

Re: K022336

Trade/Device Name: Vinyl Examination Gloves, Powdered Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: 80 LYZ Dated: September 11,2002 Received: October 1, 2002

Dear Mr. Hu:

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. Hu

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours.

Patina Curritiffor

Timothy A. Ulatowski 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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Page _ of _

510(k) Number (if known):	K022336
Device Name:	Vinyl Exam Gloves, Powdered

Indications For Use:

: 上一篇:

and the control of the count

100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

A Vinyl patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE II NEEDED)

Prescription Use	OR	Over-The-Counter Use X
(Per 21 CFR 801.109)		(Optional Format 1-2

(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:	K022336

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.