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 a 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, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D-5250-00-4.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the "Powder Free Sterile Vinyl Glove (Clear & Yellow)" device, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Physical and Dimensions	Based on ASTM-D-5250-00 (Inspection Level S-2, AQL 4.0)	"All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 4.0."
Pinhole/Water Leak	FDA 1000 ml. Water Fill Test based on ASTM D5151-99 (AQL 2.5, Inspection Level I)	"The FDA 1000 ml. Water Fill Test based on ASTM D5151-99 was also conducted with samplings of AQL 2.5, Inspection Level I, meeting these requirements."
Primary Skin Irritation	No primary skin irritant reactions	"Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions."
Skin Sensitization	No sensitization (allergic contact dermatitis) reactions	"Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions."
Residual Powder	No more than 2 mg powder per glove (based on ASTM-D6124-01 for Starch)	"A residual Powder Test that based on ASTM-D6124-01 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)."
Overall Standard Conformance	Conforms fully to ASTM D-5250-00 and applicable 21 CFR references	"Shijiazhuang Hongxiang Plstic Products Co., Ltd.'s Powder Free Sterile Vinyl Glove (Clear& Yellow) conform fully to ASTM D-5250-00" standard as well as applicable 21 CFR references..."

Study Details

Sample size used for the test set and the data provenance:
- The document mentions "samplings of AQL 2.5, Inspection Level I" for the water fill test and "Inspection Level S-2, AQL 4.0" for physical and dimensions testing. These are statistical sampling plans from ASTM standards, which define the number of units to be inspected from a lot and the maximum number of defects allowed for the lot to be accepted. However, the exact numerical sample size (e.g., how many gloves were tested in total for each test) is not explicitly stated.
- Data Provenance: The tests were conducted by the manufacturer, Shijiazhuang Hongxiang Plastic Products Co., Ltd., presumably in China ("Shijiazhuang Hongxiang Plastic Products Co., Ltd. New High Technologies Industrial Zone Luquan City, Hebei, China"). The data is retrospective as it was collected before the 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a medical glove, and the "ground truth" for its performance is established through standardized physical, chemical, and biological tests, not through expert human interpretation or diagnosis.
Adjudication method for the test set:
- Not applicable. As the "ground truth" is based on objective measurements against engineering standards, there is no need for expert adjudication. The results are quantitative (e.g., pass/fail a water leak test, measure powder content).
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 medical device (a glove), not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies involving human readers and AI are irrelevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical product (a glove), not an algorithm or software. Its performance is assessed through direct physical and chemical testing.
The type of ground truth used:
- Standardized Physical, Chemical, and Biological Tests. The ground truth is established by meeting predefined criteria set forth in recognized industry standards like ASTM D-5250-00, ASTM D5151-99, and ASTM D6124-01, as well as biocompatibility testing (primary skin irritation and sensitization).
The sample size for the training set:
- Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This product is a physical device, not an AI model. Its manufacturing process is controlled to meet specifications, but there isn't a training dataset in the AI sense.
How the ground truth for the training set was established:
- Not applicable. As explained above, there is no "training set" in the context of an AI algorithm for this device. The manufacturing process is designed and verified to produce gloves that consistently meet the established performance standards.

Summary

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FEB 1 4 2006

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. Guixi Liu Shijiazhuang Hongxiang Plastic Products Co., Ltd. New High Technologies Industrial Zone Luquan City, Hebei, China

elimination

Date Summary Prepared: November 28, 2005

2. Name of the Device:

Shijiazhuang Great Eagle Plastic Products Co., Ltd. Powder Free Sterile Vinyl/Glove (Clear&Yellow)

3. Predicate Device Information:

Shijiazhuang Great Eagle Plastic Products Co., Ltd. Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves (K992861)

4. Device Description:

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D-5250-00-4.

5. Intended Use:

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6. Comparison to Predicate Devices:

Shijiazhuang Hongxiang Plastic Products Co., Ltd.'s Powder Free Sterile Vinyl Glove (Clear & Yellow) is substantially equivalent in safety and effectiveness to the Shijiazhuang Great Eagle Plastic Products Co., Ltd., Syntheric Powder Free (Yellow) Vinyl Patient Examination Gloves.

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

The standards used for Shijiazhuang Hongxiang Plastics Products Co., Ltd glove production are based on ASTM-D- 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 based on ASTM D5151-99 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.

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

A residual Powder Test that based on ASTM-D6124-01 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. Discussion of Clinical Tests Performed:

Not Applicable - There is no hypoallergenic claim.

9. Conclusions:

Shijiazhuang Hongxiang Plstic Products Co., Ltd.'s Powder Free Sterile Vinyl Glove (Clear& Yellow) conform fully to ASTM D-5250-00" 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/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized depiction of a human figure, with three abstract shapes representing the head, body, and legs. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" which is arranged in a circular pattern around the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 4 2006

SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO, LTD C/O Ms. Micky Lin Gloveco, Inc. 3973 Schaefer Ave. Chino, California 91710

Re: K053523

. K055523
Trade/Device Name: Powder Free Sterile Vinyl Glove (Clear and Yellow) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: Class I Product Code: 80LYZ Dated: January 30, 2006 Received: January 31, 2006

Dear Ms. Lin:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have to rowed young young determined the device is substantially equivalent (for the receiced above and nave aboute) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mensiale commerce prior to that have been reclassified in accordance with the provisions of Amendinents, or to actives that tic Act (Act) that do not require approval of a premarket the rederal I vou, Drag, and Commay, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provision 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 (1 Mr), it may be subject to back of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roundsh further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Lin

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA Sissuance of a saoomarks with other requirements
mean that FDA has made a determination that your device complies with of acception mean that I DA has made a deceminations administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other major in of the Act of ally rederal statutes and regaraters, including, but not limited to: registration You must comply with an the Free Proq. 21 CFR Part 801); good manufacturing practice. and ifsung (21 CFR Tart 807), aboling (21 CFR (OS) regulation (21 CFR Part 820); and if requirements as set form in the quality byttens (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 5 10(k) This letter will anow you to objal finding of substantial equivalence of your device to a premits in the cation. THE PDF Intelling a 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), If you desire specific advice for Jour see at (240) 276-0115. Also, please note the regulation in prease contact the Other of Ochiphants and (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain 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,

Suttie Y. Michael DMD

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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ATTACHMENT A

INDICATION FOR USE

510 (k) NUMBER (IF KNOW): 上一篇55522

Shijiazhuang Hongxiang Plastic Prodcuts Co., Ltd. APPLICANT: Powder Free Sterile Vinyl Examination Glove (Clear & DEVICE NAME: Yellow)

INDICATIONS FOR USE:

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

Preseription 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)

	Shala A. Murphy
	2/14/04

Division of Anesthesiology, General Hospital,
Master Control, Dental Devices

	K053523
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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.