A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

A patient examination glove is 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

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 800.6250. Powdered Vinyl Patient Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Shijiazhuang Great Vision Plastics Products Co., Ltd. Synthetic Powdered Vinyl Patient Examination Gloves.

Important Note: The provided document is a 510(k) summary for a medical device (patient examination gloves). For this type of device, the "acceptance criteria" and "study" are focused on demonstrating substantial equivalence to a predicate device and meeting established performance standards (ASTM). This is different from the acceptance criteria and studies for AI/ML-driven diagnostic devices, which often involve sensitivity, specificity, and reader studies.

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Physical and Dimensions	ASTM Standard D5250-92	Meets all requirements (Inspection Level S-2, AQL 4.0)
Pinhole/Barrier Integrity	FDA 1000 ml. Water Fill Test	Meets requirements (Inspection Level S-4, AQL 2.5)
Biocompatibility	Primary Skin Irritation & Skin Sensitization (allergic contact dermatitis) testing	No primary skin irritant or sensitization reactions
General Requirements	Applicable 21 CFR references (e.g., GMP)	Conforms fully to applicable 21 CFR references
Labeling	No special claims (e.g., no hypoallergenic claim)	No special labeling claims, no claim of hypoallergenic

Study Details

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size:
  - For Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0. (Specific number of gloves not stated, but defined by AQL statistical sampling plan).
  - For FDA 1000 ml. Water Fill Test: Inspection Level S-4, AQL 2.5. (Specific number of gloves not stated, but defined by AQL statistical sampling plan).
  - For Primary Skin Irritation and Skin Sensitization: Not specified in the summary.
- Data Provenance: Not explicitly stated, but implied to be from testing conducted by Shijiazhuang Great Vision Plastics Products Co., Ltd. in China, as manufacturing and submission are from this company. The studies are likely prospective, as they are part of the premarket submission process to demonstrate compliance.
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 is not applicable in the context of device performance testing for examination gloves. "Ground truth" is established by adherence to clear, measurable engineering and biological standards (ASTM D5250-92, FDA water fill test, biocompatibility protocols) rather than expert human interpretation of complex data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Performance is determined by objective physical and chemical tests against defined standards, not by human interpretation requiring 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 an examination glove, not an AI or diagnostic imaging device that would involve human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an examination glove, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device is based on established industry standards and regulatory testing protocols:
  - ASTM Standard D5250-92 (for physical characteristics)
  - FDA 1000 ml. Water Fill Test (for pinhole/barrier integrity)
  - Biocompatibility testing protocols (for skin irritation and sensitization)
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set. The "training" for manufacturing would be quality control and process adherence.
How the ground truth for the training set was established:
- Not applicable, as there is no training set in the AI/ML sense. The "ground truth" for manufacturing quality assurance is established through the continuous adherence to the standards and specifications listed above, enforced through ongoing quality management systems.

Summary

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510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: _K 9925334

1. Submitter's Identification:

Ms. Fang Yi Liu Shijiazhuang Great Vision Plastics Products Co., Ltd. Cangshi Road (S) Jinzhou City, Hebei Province P.R. China

Date Summary Prepared: July 14, 1999

2. Name of the Device:

Shijiazhuang Great Vision Plastics Products Co., Ltd. Synthetic Powdered Vinyl Patient Examination Gloves

3. Predicate Device Information:

Sunmax Enterprise Shanghai Co., Ltd. Powdered Vinyl Patient Examination Gloves, K#960746 Shanghai Super Gloves Company, Ltd. Powdered Vinyl Patient Examination Gloves, K#974151

4. Device Description:

5. Intended Use:

6. Comparison to Predicate Devices:

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Shiijazhuang Great VisionPlastics Products Co., Ltd. Synthetic Powdered Vinyl Patient Examination Gloves, is substantially equivalent in safety and effectiveness to the Sunmax Enterprise Shanghai Co., Ltd. Powdered Vinyl Patient Examination Gloves and the Shanghai Super Gloves Company, Ltd. Powder Vinyl Patient Examination Gloves.

7. Discussion of Non-Clinical tests Performed for Determination of Substantial Equivalence are as follows:

The standards used for Shijiazhuang Great Vision Plastics Products Co., Ltd. glove production are based on ASTM-D-5250-92. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 4.0.

The FDA 1000 ml. Water Fill Test was also conducted with samplings of AOL 2.5. Inspection Level S-4, meeting these requirements. Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.

There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.

Discussion of Clinical Tests Performed: 8.

Not Applicable - There is no hypoallergenic Claim.

9. Conclusions:

Shijiazhuang Great Vision Plastics Co., Ltd. Synthetic Vinyl Patient Examination gloves (Powdered) conform fully to ASTM-D-5250-92 standard as well as applicable 21 CFR references, and, meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.

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MAR 2 9 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shijiazhuang Great Vision Plastics Products Co., Ltd. C/O Ms. Karen Abell Basic Medical Industries, Inc. 13945 Magnolia Avenue Chino, California 91710

Re : K992554 Synthetic Powdered Vinyl Patient Examination Trade Name: Gloves Requlatory Class: I Product Code: LYZ February 28, 2000 Dated: February 28, 2000 Received:

Dear Ms. Abell:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your

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Page 2 -Ms. Abell

premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment A

Page 1 of 1

510(k) NUMBER (IF KNOWN) K ag 25524 Shijiazhuang Great Vision Plastics Products Co., Ltd. DEVICE NAME: INDICATIONS FOR USE: Synthetic Powdered Vinyl Patient Examination Gloves-Powdered

A patient examination glove is disposable device intended for medical purposes that is 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 IF NEEDED.)

	Concurrent of CDRH, Office of Device Evaluation (ODE)
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Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter-Use(Optional Format 1-2-96)	✓
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	Barito for Clin(Division Sign-Off)
	Division of Dental, Infection Control,and General Hospital Devices
510(k) Number	K99 2554

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.