(204 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.
POWDER-FREE LATEX EXAM GLOVES, WITH PROTEIN LABELING (50 ug/g or less)
This document is a 510(k) Pre-market Notification for Powder-Free Latex Exam Gloves. The information provided outlines the device's characteristics and its substantial equivalence to previously approved devices. However, it does not contain the type of detailed information typically found in a study proving a device meets specific acceptance criteria in the context of AI/ML or complex diagnostics. Instead, it focuses on compliance with established standards for medical gloves.
Given this context, I will interpret "acceptance criteria" as the performance standards outlined for medical gloves and "study" as the testing reported in the 510(k) summary. Many of the requested fields (like sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, training set, etc.) are not applicable to this type of device and submission.
Here's the information extracted and interpreted based on the provided document:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| Physical Properties: | |
| ASTM D 5712-95 | Met or exceeded |
| ASTM D 3578-01 | Met or exceeded |
| ASTM D 6124-97 | Met or exceeded |
| ASTM D 5151-00 | Met or exceeded |
| ISO 2859 | Met or exceeded |
| Biocompatibility: | |
| Cytotoxicity (Agar Diffusion) | Successful Results |
| Dermal Sensitization | Successful Results |
| Primary Skin Irritation | Successful Results |
| Protein Labeling: | 50 ug/g or less |
Study Details (as applicable to this device type)
-
Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document. The standards listed (e.g., ASTM D 5712-95, ISO 2859) define specific sampling plans and test methods, but the number of units tested is not reported here.
- Data Provenance: The device is manufactured by HYCARE INTERNATIONAL CO., LTD. in Hat-Yai, Songkhla, Thailand. The testing would have been conducted by or for this manufacturer. The document doesn't specify if the data is retrospective or prospective, but typically for this type of product, it would be prospective testing of manufactured samples.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For medical gloves, "ground truth" as a concept for expert assessment (e.g., of images or diagnoses) is not relevant. Performance is determined by objective physical and chemical testing against established standards.
-
Adjudication method for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of complex data (e.g., medical images). For medical gloves, adherence to standards is determined by direct measurement and observation during testing, not by expert consensus or adjudication.
-
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 (latex examination gloves), not an AI/ML diagnostic tool or an imaging system. MRMC studies are not relevant to its evaluation.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
-
The type of ground truth used:
- For this device, "ground truth" is defined by the objective specifications and quantifiable limits set by international and national standards (e.g., ASTM D 5712-95 for tensile strength, elongation, etc.; ASTM D 6124-97 for extractable protein levels; ISO 2859 for sampling procedures and acceptance quality limits). Biocompatibility is assessed based on in vitro and in vivo (animal, not human) tests with established criteria for response.
-
The sample size for the training set:
- Not Applicable. This device does not involve machine learning; therefore, there is no "training set."
-
How the ground truth for the training set was established:
- Not Applicable. As there is no training set, this question is not relevant.
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(JUL 3 0 2002
510(k) SUMMARY
| Submitted For: | HYCARE INTERNATIONAL CO., LTD.457/2 Moo 3, Airport Road, Hat-YaiSongkhla, 90110, Thailand |
|---|---|
| Submitted By: | TUCKER & ASSOCIATESOfficial Correspondent for Hycare International Co., Ltd.JANNA P. TUCKER, President-CEO198 Avenue de la D'emeraldSparks, NV 89434-9550Phone:775-342-2612Fax:775-342-2613E-Mail:Tuckerjan@aol.com |
| Date of Submission: | 08 July 2002 |
| Device Name: | POWDER-FREE LATEX EXAM GLOVES,WITH PROTEIN LABELING (50 ug/g or less)Class I Device, 80LYY |
| Proprietary Name: | (Multiple Labels) Powder-Free Latex Exam Gloves,With Protein Labeling (50 ug/g or less) |
| Labels/Labeling: | This device will be marketed to healthcare professionals atDentist and Doctor Offices, Laboratories, Clinics andHospitals through its distributors for the intended use. |
| Intended Use: | A patient examination glove is a disposable device intendedfor medical purposes that is worn on the examiner's handor finger to prevent contamination between patient andexaminer. |
| Substantial Equivalence: | Both in its intended use and/or physicalcharacteristics, this device is equivalent to devicescurrently marketed by U.S. companies. It is substantiallyEquivalent to the devices manufactured by SGMP Co.,Ltd. K000391, and Supergrade Healthcare, SDN BHDK0114134. |
Atch 7 (Revised 7-12-02)
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510k) Summary page 2.
Test Results (Means and/or Successful Results:
This device has met or exceeded the following standards and/or tests:
ASTM D 5712-95 ASTM D 3578-01 ASTM D 6124-97 ASTM D 5151-00 ISO 2859
Cytotoxicity (Agar Diffusion)
Bio-Compatibility: Dermal Sensitization Primary Skin Irritation
Conclusion:
This device is substantially equivalent to the devices approved as K000391 and K014134.
Atch 7
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or a similar feature.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2002
Hycare International Company Limited C/O Ms. Janna P. Tucker Tucker & Associates 198 Avenue De La D' Emerald Sparks. Nevada 89434-9550
Re: K020042
Trade/Device Name: Hycare Latex Examination Glove, Powder Free, with Protein Labeling Claim ( 50 Micrograms or Less ) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: July 1, 2002 Received: July 5, 2002
Dear Ms. Tucker:
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.
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.
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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division 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.qoy/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski
Ulatowski 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
| APPLICANT: | HYCARE INTERNATIONAL, CO., LTD |
|---|---|
| 510(k) NUMBER: | K020042 |
| DEVICE NAME: | POWDER-FREE LATEX EXAMGLOVES, WITH PROTEIN LABELING(50 ug/g or less) |
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Chiu S. Lin
(Division Sign-Off) Consion of Dental, Infection Control, Seneral Hospital Devices : " ivember ____________________________________________________________________________________________________________________________________________________________________
Atch 1
1 July 02
§ 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.