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 Hospital and Personal Use Device panel as Class I, 21 CFR 880.6250, Power Free Vinyl Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device: Supermax Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Glove. This is a Class I device, and the submission focuses on demonstrating substantial equivalence to a predicate device, rather than a novel AI system or diagnostic tool requiring complex clinical studies.

Therefore, many of the requested categories related to AI performance, multi-reader studies, and detailed ground truth establishment for complex medical imaging or diagnostics are not applicable to this type of device submission.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Physical and Dimensions Testing:	Meets requirements of ASTM standard D-5250-06e1.
Pinhole Requirements:	Meets FDA 1000 ml. Water Fill Test requirements (AQL 2.5, inspection level I).
Biocompatibility - Primary Skin Irritation:	No primary skin irritant reactions.
Biocompatibility - Skin Sensitization:	No sensitization reactions (allergic contact dermatitis).
Powder-Free Claim:	Contains no more than 2 mg powder per glove (based on ASTM D-6124-06).

Study Information

Sample sizes used for the test set and the data provenance:
- Pinhole Test: Inspection level I, AQL 2.5 (The exact sample size isn't explicitly stated but is determined by these AQL parameters).
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0 (The exact sample size isn't explicitly stated but is determined by these AQL parameters).
- Biocompatibility Tests: The text mentions "testing was conducted" but does not specify sample size or provenance (e.g., human subjects, animal studies, in-vitro).
- Powder Test: The text mentions "at finished inspection" but does not specify a separate sample size for the test.
- Data Provenance: Not explicitly stated, but typically for such product testing, it would be conducted at the manufacturing site or a certified testing laboratory.
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 glove performance involves objective physical and chemical measurements governed by established ASTM standards and FDA test methods, not expert interpretation of medical data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically for subjective assessments (e.g., image interpretation). These tests involve objective pass/fail criteria based on measured values against standards.
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 patient examination glove, not an AI-powered diagnostic tool. MRMC studies are not relevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical product, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" is based on pre-defined, objective ASTM standards and FDA test methods for physical properties, dimensions, pinhole defects, biocompatibility, and residual powder. These are measurable values against a threshold.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established:
- Not applicable. No training set is involved.

Summary

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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: K 093798

1. Owner's Identification:

Mr. Zhanmin Lv Supermax Plastic Products Co., Ltd. 314 Dragon River East Road, Luquan, Hebei Province, China 050000 Date Summary Prepared: November 2, 2009

2. Name of the Device:

Supermax Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Glove

3. Predicate Device Information:

Shijiazhuang Great Eagle Plastic Products Co., Ltd Synthetic Powder-Free Vinyl Patient Examination Gloves (K983207)

4. Device Description:

5. Intended 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.

6. Comparison to Predicate Devices:

Supermax Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Glove is substantially equivalent in safety and effectiveness to the Shijiazhuang Great Eagle Plastic Products Co., Ltd.'s Synthetic Powder-Free Vinyl Patient Examination Gloves.

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K093798

EXHIBIT #1 Page 2 of 2

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

The standards used for Supermax Plastic Products Co., Ltd.'s glove production are based on ASTM D-5250-06e1. 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 AQL 2.5, inspection level I, 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-6124-06 for powder 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:

Supermax Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Glove conform fully to ASTM D-5250-06e1 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. The device herein mentioned is as safe, as effective, and performs as well as or better than the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three wavy lines representing its wings. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

Supermax Plastic Products Company, Limited C/O Ms. Jie Liu Project Manager Surprotect Incorporated 3973 Schaefer Avenue Chino, California 91710

FEB 2 3 2010

Re: K093798

Trade/Device Name: Powder Free Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: 1 Product Code: LYZ Dated: November 2, 2009 Received: December 10, 2009

Dear Ms. Liu:

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 - Ms. Liu

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Susan Runoe

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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Attachment A

INDICATION FOR USE

510 (k) NUMBER (IF KNOW): APPLICANT: DEVICE NAME:

K 093798 Supermax Plastic Products Co., Ltd. Powder Free Vinyl Patient 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.

Elijat F.C. Laverie - Will

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

K693798 510(k) Number:

Prescription Use (Part 21 CFR 801 Subpart D) AND/ OR

Over-The-Counter-Use _ 4 (21CFR 801Subpart C)

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

Concurrent of CDRH, Office of Device Evaluation (ODE)

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.