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 Vinyl Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06el.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets those criteria:

Acceptance Criteria and Device Performance for Better Care Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Glove (K092296)

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines an equivalency study based on established ASTM standards and FDA requirements rather than defining novel acceptance criteria for a new type of device. The acceptance criteria are therefore the requirements set by the cited standards for this device type.

Acceptance Criteria (Set by Standards)	Reported Device Performance (as per submission)
Physical and Dimensions Testing: (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.
Pinholes (Water Fill Test): (FDA 1000 ml. Water Fill Test AQL 2.5, inspection level 1)	The FDA 1000 ml. Water Fill Test was conducted with samplings of AQL 2.5, inspection level 1, meeting these requirements.
Biocompatibility (Primary Skin Irritation):	Primary Skin Irritation testing was conducted with results showing no primary skin irritant reactions.
Biocompatibility (Skin Sensitization/Allergic Contact Dermatitis):	Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no sensitization reactions.
Residual Powder: (Based on ASTM D-6124-06)	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).
Labeling Claims (Hypoallergenic):	No claim of hypoallergenic is made.
Overall Conformity:	Conform fully to ASTM D-5250-06e1 standard as well as applicable 21 CFR references.

2. Sample Size Used for the Test Set and Data Provenance:

Physical and Dimensions Testing: "Inspection level S-2, AQL 4.0". The specific numerical sample size is not explicitly stated but is implicitly defined by the AQL (Acceptance Quality Limit) and inspection level (S-2) within Quality Assurance sampling plans, likely based on ANSI/ASQ Z1.4 (or equivalent) tables.
Pinhole (Water Fill Test): "samplings of AQL 2.5, inspection level 1". Similar to above, the specific numerical sample size is not explicitly stated, but defined by AQL and inspection level. This is a common sampling plan for medical gloves.
Biocompatibility (Primary Skin Irritation and Skin Sensitization): The specific sample size (e.g., number of test subjects or animals) is not provided.
Residual Powder Test: The specific sample size is not provided, but it's stated to be conducted "at finished inspection."

Data Provenance: The document does not explicitly state the country of origin for the data collection for these tests. However, the submitter is "Better Care Plastic Products Co., Ltd." from "Hebei Province 050000" in China, suggesting the testing was likely conducted in or contracted by the manufacturing company in China, following international standards. The tests are retrospective, performed on manufactured products.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This submission describes pre-market testing for a Class I medical device (patient examination glove), which relies on objective performance measurements against established standards, not expert consensus on interpretations of complex data (like image analysis). Therefore, the concept of "experts establishing ground truth for the test set" in the context of, for example, multiple radiologists reviewing images, does not directly apply here.

The "ground truth" for glove performance is defined by the objective metrics and thresholds specified in the ASTM standards (D-5250-06e1, D-6124-06) and FDA test methods (1000 ml. Water Fill Test). The "experts" involved would be qualified laboratory technicians, engineers, and quality assurance personnel who are trained in performing these specific tests and interpreting the results according to the published standards. Their qualifications would involve training in laboratory procedures, statistical quality control, and knowledge of the relevant ASTM and FDA guidelines for medical device testing.

4. Adjudication Method for the Test Set:

Adjudication methods like "2+1" or "3+1" are typically used when there's subjective interpretation involved, such as clinical reads or image analysis, where multiple experts might disagree. In this case, the tests are objective:

Physical dimensions are measured.
Pinhole tests are pass/fail based on water leakage.
Irritation/sensitization tests are based on observed reactions or lack thereof.
Residual powder is measured quantitatively.

Therefore, a formal "adjudication method" in the sense of reconciling differing expert opinions is not applicable. The results are directly derived from the test protocols. Any potential disputes would arise from re-testing, calibration, or auditing of the testing facility, not from subjective expert disagreement on the outcome of a particular test.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret outputs, and the goal is to assess how a new technology (e.g., AI) impacts human performance. A patient examination glove is a simple physical barrier device, and its safety and effectiveness are assessed through physical, chemical, and biological testing as described, not by human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This is not applicable as the device is a physical product (a glove), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The ground truth used for demonstrating compliance is objective performance data derived from standardized laboratory tests and measurements. This includes:

Physical Measurements: Tensile strength, elongation, dimensions, etc., against ASTM D-5250-06e1 specifications.
Leakage/Barrier Integrity: Pass/fail rates for the FDA 1000 ml. Water Fill Test.
Biocompatibility Data: Results from primary skin irritation and skin sensitization tests (e.g., absence of observed reactions).
Chemical Analysis: Quantitative measurement of residual powder against ASTM D-6124-06 and the "<2 mg per glove" claim.

8. The Sample Size for the Training Set:

This question is not applicable. The device is a physical product (a glove), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process itself (Good Manufacturing Practices) and quality control throughout production could be considered an ongoing "training" equivalent in the sense of maintaining product quality, but it's not a data-driven training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable, as there is no "training set" for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains a sequence of handwritten characters, specifically "Ko92296". The characters are written in a simple, clear style, with each digit and letter easily distinguishable. The sequence appears to be a code or identifier, possibly a serial number or reference code.

OCT 2 1 2009

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EXHIBIT #I 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:

l . Submitter's Identification:

Mr. Guixi Liu Better Care Plastic Products Co., Ltd. Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province 050000 Date Summary Prepared: June 30, 2009

Name of the Device: Better Care Plastic Products Co., Ltd. Powder Free Viny! 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:

Classified by FDA's General and Plastic Surgery 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-5250-06el .

5. Intended Use:

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

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6. Comparison to Predicate Devices:

Better Care 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.

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

The standards used for Better Care 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 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-6124-06 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:

Better Care 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.

ﺎ۔

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circle around the symbol. The caduceus is depicted in black, and the text is also in black. The overall design is simple and recognizable, representing the department's focus on health and human welfare.

Public Health Service

DEC 16 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

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

Re: K092296

Trade/Device Name: Powder Free Vinyl Patient Examination Glove Regulation Number: 21CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: 1 Product Code: LYZ Dated: September 30, 2009 Received: October 1, 2009

Dear Ms. Liu:

This letter corrects our substantially equivalent letter of October 21, 2009.

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 (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 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 vours,

Anthony V. Watkins

Susan Runner, D.D.S., M.A. Acting 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:

K092296 Better Care 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.

Prescription Use (Per 21 CFR 801.109) OR

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

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

Acurrent of CDRH, Office of Device Evaluation (ODE)
(Division Sign-O;

Division of Anestr sology. General Hospital Intection. Control, Dental Devices

510(k) Number: K 092296

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.