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 A patient 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 Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the Powder Free Vinyl Patient Examination Gloves:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Test Method/Requirement	Reported Device Performance
ASTM D-5250-00E4	Physical and dimensions testing	"All testing meets requirements for physical and dimensions testing conducted on gloves."
FDA 1000 ml. Water Fill Test	AQL 2.5, Inspection Level I	"Meeting these requirements." (Implies meeting AQL 2.5, Inspection Level I)
Primary Skin Irritation	No primary skin irritant reactions	"No primary skin irritant reactions."
Skin Sensitization	No sensitization reactions (allergic contact dermatitis)	"No sensitization reactions."
Residual Powder Content	ASTM D-6124-06 (target: no more than 2 mg powder per glove)	"Insure that our gloves meet our 'powder-free' claims (contain no more than 2 mg powder per glove)."
Pinhole Requirements	FDA requirements	"Meets pinhole FDA requirements."
Biocompatibility	(Implied by skin irritation/sensitization tests)	"Meets biocompatibility requirements."

2. Sample Sizes and Data Provenance

Test Set Sample Size: For the ASTM D-5250-00E4 physical and dimensions testing, the inspection level was S-2, AQL 4.0. For the FDA 1000 ml. Water Fill Test, the inspection level was I, AQL 2.5. The exact number of units sampled for each test is not explicitly stated, but these AQL (Acceptable Quality Level) values dictate the sampling plan.
Data Provenance: The testing was conducted by Super Safe Plastic Products Co., Ltd. in China. The data is retrospective, as it describes tests performed on the manufactured gloves.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable to this type of device. The ground truth for performance of examination gloves is established through standardized physical, chemical, and biological tests, not through expert human interpretation or consensus.

4. Adjudication Method for the Test Set

This is not applicable as the performance is measured purely through objective, standardized tests, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable. This type of study is used for diagnostic or screening devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This device is a patient examination glove.

6. Standalone (Algorithm Only) Performance Study

This is not applicable. This device does not involve an algorithm or software. Its performance is determined by its physical and material properties.

7. Type of Ground Truth Used

The ground truth used for this device's acceptance is based on:

Standardized Test Methods and Criteria: Specifically, ASTM D-5250-00E4 and ASTM D-6124-06 for physical properties and residual powder, and FDA requirements for water fill/pinholes, skin irritation, and sensitization. These standards define the objective measures for performance.

8. Sample Size for the Training Set

This is not applicable. This device does not use machine learning or algorithms, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

This is not applicable for the same reason as above; there is no training set.

Summary

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FEB 1 6 2007

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: _______________________________________________________________________________________________________________________________________________

1. Submitter's Identification:

Mr. Lu Wenxin Super Safe Plastic Products Co., Ltd. Meng Er Village, Pingshan County, Shijiazhuang, Hebei, China 050401

Date Summary Prepared: September 20, 2006

2. Name of the Device:

Super Safe Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves

3. Predicate Device Information:

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

4. Device Description:

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.

5. Intended Use:

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K070030

EXHIBIT #1 Page 2 of 2

6. Comparison to Predicate Devices:

Super Safe Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves is substantially equivalent in soft in substitiveness to the Shijiazhuang Great Exploy Plastic Products Co., Ltd.'s Synthetic Vinyl Powder Free Patient Examination Gloves,

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

The standards used for Super Safe Plastic Products Co., Ltd.'s glove production are

based on ASTM-D-5250-00 €4. 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 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:

Super Safe Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves conform fully to ASTM D-5250-00e4 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle, with its wings forming a stylized, flowing design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Super Safe Plastic Products Company Limited C/O Ms. Kathy Liu Gloveco, Incorporated 3973 Schaefer Avenue Chino, California 91710

FEB | & 2007

Re: K070030

Trade/Device Name: Powder Free Vinyl Patient Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: December 28, 2006 Received: January 3, 2007

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.

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 - 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); 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

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INDICATION FOR USE

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

Ko 20030 Super Safe 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 A patient examiner's hand or finger to prevent contamination between patient and examiner.

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use X (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)

Elaine S. Marshall for S. Murphy

11:4

K070030

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.