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 purpose 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 880.6250, Power-Free Nitrile Patient Examination Glove, 80 LZA, and meets all requirements of ASTM standard D-6319-00€3

AI/ML Overview

This document describes the validation of a medical device, specifically a "Powder Free Nitrile Blue Textured Examination Glove." However, it focuses on the physical and biological characteristics of the glove and its substantial equivalence to a predicate device, rather than the performance of an AI or software-based medical device.

Therefore, many of the requested categories (e.g., sample size for test set, ground truth experts, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of device submission.

Here's the information that can be extracted and presented, with clarifications for the questions that don't apply:

Acceptance Criteria and Reported Device Performance

Criteria	Reported Device Performance
Physical and Dimensions Testing	Meets requirements of ASTM standard D-6319-00€3. Inspection level S-2, AQL 4.0.
Water Fill Test (Pinhole)	Meets requirements of the FDA 1000 ml. Water Fill Test with samplings of AQL 2.5, inspection level G-1.
Primary Skin Irritation	Results show no primary skin irritant reactions.
Skin Sensitization (Allergic Contact Dermatitis)	Results show no sensitization reactions.
Residual Powder	Meets "powder-free" claims (contains no more than 2 mg powder per glove) based on ASTM D-6124-01 for Starch at finished inspection.
Compliance with ASTM Standard	Conforms fully to ASTM D-6319-00E standard.
Compliance with 21 CFR References	Conforms fully to applicable 21 CFR references (specifically 21 CFR 880.6250, specifying Class I, Power-Free Nitrile Patient Examination Glove, 80 LZA).
Labeling Claims	No special labeling claims; does not claim gloves as hypoallergenic. (This is a statement of compliance with labeling requirements rather than a performance metric, but it confirms adherence to the device description).

Study Details (as applicable for a physical medical glove)

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a single "test set" for performance evaluation in the way a software algorithm would be. Instead, testing was conducted on samples from manufacturing lots based on AQLs (Acceptable Quality Levels).
  - Physical and Dimensions Testing: Inspection level S-2, AQL 4.0.
  - Water Fill Test: AQL 2.5, inspection level G-1.
- Data Provenance: Not specified, but generally, such testing would be conducted by the manufacturer (Syntex Healthcare Products Co., Ltd.) in China, where the device is manufactured. The testing is likely retrospective in the sense that it's performed on finished products, but it represents ongoing quality control.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. The "ground truth" for a physical glove is determined by established physical and chemical test methods against defined standards (ASTM, FDA). It does not involve expert consensus in the way an AI diagnostic tool would for clinical images.
Adjudication method for the test set:
- Not Applicable. Pertains to expert review for ambiguous cases in diagnostic studies, not physical product 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:
- Not Applicable. This is a physical, disposable medical device, not an AI software.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical, disposable medical device, not an AI algorithm.
The type of ground truth used:
- Established Standards and Test Methods: The ground truth for this device's performance is based on recognized consensus standards (ASTM D-6319-00€3, ASTM D-6124-01) and regulatory test methods (FDA 1000 ml. Water Fill Test), as well as biocompatibility testing for skin irritation and sensitization.
The sample size for the training set:
- Not Applicable. This refers to machine learning algorithms, which are not involved here.
How the ground truth for the training set was established:
- Not Applicable. As above, no training set for an AI algorithm.

Summary

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

EXHIBIT #1 Page 1 of 2

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: K052877

1. Submitter's Identification:

Mr. Hao Jun Jie Syntex Healthcare Products Co., Ltd. No. 1 Fanjiazhuang Industrial Zone Xinji City, Hebei, China

Date Summary Prepared: September 15, 2005

2. Name of the Device:

Syntex Healthcare Products Co., Ltd. Powder Free Nitrile Blue Textured Examination Glove

3. Predicate Device Information:

Shanghai Poseidon Plastic Products Co., Ltd. Nitrile Exam Gloves, Powder-Free, Color Blue (K001128)

4. Device Description:

5. Intended Use:

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

6. Comparison to Predicate Devices:

Syntex Healthcare Products Co., Ltd.'s Powder Free Nitrile Blue Textured Examination Glove is substantially equivalent in safety and effectiveness to the Shanghai Poseidon Plastic Products Co., Ltd.'s Nitrile Exam Gloves, Powder-Free, Color Blue.

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows:

The standards used for Syntex Healthcare Products Co., Ltd.'s glove production are based on ASTM-D-6319-00-3. 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 G-1, 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.

A Residual Powder Test that based on ASTM D-6124-01 for Starch at finished inspection is conducted to insure that our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove).

8. Labeling:

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

9. Discussion of Clinical Tests Performed:

Not Applicable - There is no hypoallergenic Claim.

10. Conclusions:

Syntex Healthcare Products Co., Ltd.'s Powder Free Nitrile Blue Textured Examination Gloves conform fully to ASTM D-6319-00E 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.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 8 2005

Syntex Healthcare Products Company, Limited C/O Ms. Micky Lin Official Correspondent Gloveco, Incorporated 3973 Schaefer Avenue Chino, California 91710

Re: K052877

Trade/Device Name: Powder Free Nitrile Blue Textured Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: September 30 2005 Received: October 13, 2005

Dear Ms. Lin:

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.

{3}------------------------------------------------

Page 2 - Ms. Lin

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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Shi-Jie Li, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Attachment A

INDICATIONS FOR USE

510(K) NUMBER (IF KNOWN): APPLICANT: DEVICE NAME:

Syntex Healthcare Products Co., Ltd. Powder Free Nitrile Blue Textured Examination Glove

INDICATIONS FOR USE:

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

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

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

concurrent of CDRH, Office of Device Evaluation (ODE)
-------------------------------------------------------

Signature
Vision Sign-Off)
Vision of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K052877

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.