(87 days)
A 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.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Patient Examination Glove, 80LYY, and meets all requirements of ASTM Standard D 3578-01aE2.
The provided text is a 510(k) summary for a medical device: "Powder Free Natural Rubber Latex Patient Examination Gloves with a Protein Labeling Claim (50 micrograms or less) and Made from Allotex® an Enzyme Treated Natural Rubber Latex." This document describes the device's characteristics and its substantial equivalence to a predicate device, rather than a study evaluating the performance of an AI-powered device. Therefore, much of the requested information, such as sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, and training set details, is not applicable to this type of regulatory submission.
However, I can extract the relevant "acceptance criteria" (which in this context refers to performance standards for the gloves) and the "reported device performance" based on the non-clinical tests performed.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard / Requirement) | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: ASTM D 3578-01aE2, Inspection Level S-2, AQL 4.0 | Meets requirements for Physical and Dimensions Testing |
| Water Fill Test: "Maximum Fill" test, AQL 2.5, Inspection Level G-1 | Meets requirements |
| Primary Skin Irritation | No primary skin irritant reactions |
| Skin Sensitization (allergic contact dermatitis) | No sensitization reactions |
| Residual Powder Test: ASTM D6124-01 for Starch (no more than 2 mg powder per glove) | Meets "powder-free" claims (contains no more than 2 mg powder per glove) |
| Protein Labeling Claim: 50 micrograms or less (implied standard from predicate) | Meets protein labeling claim (50 micrograms or less) |
| Pinhole Requirement: FDA requirements (implied) | Meets pinhole FDA requirements |
| Biocompatibility Requirements (implied) | Meets biocompatibility requirements |
| Labeling Claims (implied) | Meets labeling claims |
| Overall Standard Conformance: ASTM D 3578-01aE2 | Conforms fully to ASTM D 3578-01aE2 standard |
| Overall Regulatory Conformance: Applicable 21 CFR references | Conforms fully to applicable 21 CFR references |
2. Sample size used for the test set and the data provenance:
- Sample Size for Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0. The exact numerical sample size is not explicitly stated, but these AQL (Acceptable Quality Limit) levels refer to standard sampling plans outlined in ISO 2859 (or equivalent standards) which would dictate specific sample sizes based on lot size.
- Sample Size for Water Fill Test: AQL 2.5, Inspection Level G-1. Similar to above, the exact numerical sample size is not explicitly stated but is determined by the AQL and inspection levels.
- Sample Size for Primary Skin Irritation and Skin Sensitization: Not specified.
- Sample Size for Residual Powder Test: Not specified.
- Data Provenance: The tests were conducted by the manufacturer, Shijiazhuang Tillotson Rubber Products Co., Ltd., presumably in China (its country of origin). The data is retrospective in the sense that the tests were performed on finished products before the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as this document pertains to the physical and chemical testing of medical gloves, not the evaluation of an AI-powered diagnostic device requiring expert interpretation of outputs. The "ground truth" here is objective measurements and industrial standards.
4. Adjudication method for the test set:
Not applicable. The tests involve objective measurements against established ASTM standards and FDA requirements, not subjective expert adjudication.
5. 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 not an AI-powered device, and no human reader studies are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI-powered device.
7. The type of ground truth used:
The ground truth used for these tests includes:
- Objective Measurements against Standards: For physical properties (tensile strength, elongation, dimensions), pinholes, residual powder, and protein content.
- Biocompatibility Testing Standards: For primary skin irritation and sensitization.
- Regulatory Requirements: FDA's pinhole requirements and general biocompatibility expectations.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device; there is no training set mentioned.
9. How the ground truth for the training set was established:
Not applicable. There is no training set.
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JAN 2 8 2005
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.
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1. Submitter's Identification:
Mr. Yang Ying Shijiazhuang Tillotson Rubber Products Co., Ltd. Donggao Industrial Zone Zanhuang, Hebei Province P.R. China
Date Summary Prepared: October 06, 2004
2. Name of the Device:
Shijiazhuang Tillotson Rubber Products Co., Ltd.
Powder Free Natural Rubber Latex Patient Examination Gloves with a Protein Labeling Claim (50 micrograms or less) and Made from Allotex® an Enzyme Treated Natural Rubber Latex
3. Predicate Device Information:
Syntex Healthcare Products Co., Ltd.
Powder Free Latex Examination Glove with Protein Labeling Claim (50 micrograms or less) (K021059)
4. Device Description:
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Patient Examination Glove, 80LYY, and meets all requirements of ASTM Standard D 3578-01aE2.
5. Intended Use:
A 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.
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6. Comparison to Predicate Devices:
Shijiazhuang Tillotson Rubber Products Co., Ltd. Powder Free Natural Rubber Latex Patient Examination Gloves with a Protein Labeling Claim (50 micrograms or less) and Made from Allotex® an Enzyme Treated Natural Rubber Latex is substantially equivalent in safety and effectiveness to the Syntex Healthcare Products Co., Ltd. Powder Free Latex Examination Glove with Protein Labeling Claim (50 micrograms or less).
7. Discussion of Non-Clinical tests Performed for Determination of Substantial Equivalence are as follows:
The standards used for Shijiazhuang Tillotson Rubber Products Co., Ltd. glove production are based on ASTM D 3578-01aE2. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 4.0.
The "Maximum Fill" Water Fill Test was also conducted with samplings of AQL 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.
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 Tillotson Rubber Products Co., Ltd. Powder Free Natural Rubber Latex Patient Examination Gloves with a Protein Labeling Claim (50 micrograms or less) and Made from Allotex® an Enzyme Treated Natural Rubber Latex conform fully to ASTM D 3578-01aE2 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol of three horizontal lines that curve and flow together, resembling a stylized human form or a wave-like design.
JAN 2 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shijiazhuang Tillotson Rubber Products Company Limited C/O Mr. James Chu Official Correspondent Gloveco, Incorporated 590 West Central Avenue, #D Suite Brea, California 92821
Re: K043014
Trade/Device Name: Powder Free Natural Rubber Low Modulus Latex Patient Examination Gloves with a Protein Labeling Claim (50 Micrograms or Less) and made from Allotex an Enzyme Treated Natural Rubber Latex Regulation Number: 880. 6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: December 21, 2004 Received: January 12, 2005
Dear Mr. Chu:
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 appear and approvisions 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 (1 Mr.), I had in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Ecderal Register.
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Page 2 – Mr. Chu
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DTS Issualled of a bases and inst your device complies with other requirements If the Act or any Federal statutes and regulations administered by other Federal agencies. of the ACI of ally I edelar statutes and regisments, including, but not limited to: registration You must comply with an the Fice b rog (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 007), absitisg (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality byovisions (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) This letter will anow you to objact to and the substantial equivalence of your device to a premarket notification. - The PDF Intellis 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), If you desire specific advice to: Join as 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 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,
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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Indications for Use
510(k) Number (if known): K043014
Device Name: Powder Free Natural Rubber Low Modulus Latex Patient Examination Gloves with a Protein Labeling Claim (50 micrograms or less) and Made from Allotex an Enzyme Treated Natural Rubber Latex
Indications For Use: A patient examination glove is disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
signature
Civision Sign-Off) Olvision of Anesthesiology, General Hospital, Intection Control, Dental De
510(k) Number: K043014
§ 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.