(76 days)
Medtexx Powder free Latex Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.
MEDTEXX Powder Free Latex Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 95, Standard Specification for Rubber Examination Gloves. They are natural white in color and are powder free.
Here's an analysis of the provided information regarding the MEDTEXX POWDER FREE LATEX EXAMINATION GLOVES, focusing on acceptance criteria and supporting studies:
Assessment of the Provided Information:
The provided document describes a 510(k) premarket notification for a medical device: "MEDTEXX POWDER FREE LATEX EXAMINATION GLOVES". This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device.
It's crucial to understand that this document describes a physical medical device (gloves), not an AI/software as a medical device (SaMD). Therefore, many of the requested categories related to AI/SaMD studies (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set sample size, how ground truth was established for training set) are not applicable to this type of device.
The "acceptance criteria" here refers to the performance standards that the physical gloves must meet, primarily outlined in ASTM D 3578-95 and 21 CFR 800.20. The "study that proves the device meets the acceptance criteria" refers to non-clinical testing performed on the gloves to demonstrate compliance with these standards.
Acceptance Criteria and Device Performance for MEDTEXX POWDER FREE LATEX EXAMINATION GLOVES
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Physical Properties (ASTM D 3578-95, Standard Specification for Rubber Examination Gloves) | |
| Not explicitly detailed in the provided text, but states compliance with the standard | Gloves meet "all the current specifications listed under the ASTM Specification D 3578 - 95" |
| Freedom from Holes (21 CFR 800.20) | |
| Not explicitly detailed in the provided text, but states compliance with the regulation | Gloves meet "all the current specifications listed under... 21 CFR 800.20" |
| Biocompatibility - Primary skin irritation | No irritation |
| Biocompatibility - Delayed contact sensitization | No sensitization |
| Presence of Starch (USP iodine test) | Negative |
| Protein Content (for "Protein Label Claim") | 50 micrograms or less of total water extractable protein per gram |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated the exact number of gloves tested for each criterion. The document generally states "Testing is performed as per ASTM D 3578-95 and 21 CFR 800.20," which implies that the sample sizes specified by these standards were followed. ASTM D 3578 typically specifies sampling plans for lot acceptance.
- Data Provenance: The tests were conducted by Medtexx Industries (Thai) Company Limited, from Thailand. The data is based on retrospective testing of glove samples for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable: This device is a physical product (examination gloves), not an AI/SaMD. "Ground truth" in this context refers to objective scientific measurements and established standards (ASTM D 3578-95, 21 CFR 800.20, USP iodine test) rather than expert consensus on interpretations.
4. Adjudication Method for the Test Set
- Not Applicable: As above, this is a physical product. Adjudication methods like 2+1 or 3+1 are used for expert review of images or data in AI/SaMD contexts, not for objective physical or chemical tests of gloves. The "adjudication" is essentially the comparison of test results against the predefined quantitative and qualitative criteria in the standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No, Not Applicable: MRMC studies are specific to evaluating the diagnostic performance of human readers, often with and without AI assistance, in interpreting medical images or data. This is irrelevant for a physical product like examination gloves.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No, Not Applicable: This concept applies to AI algorithms and their performance. The gloves themselves do not have an "algorithm" to be evaluated in a standalone manner.
7. The Type of Ground Truth Used
- The "ground truth" for the performance of these gloves is based on:
- Established Industry Standards: Specifically, ASTM D 3578-95 (Standard Specification for Rubber Examination Gloves) and 21 CFR 800.20 (dealing with freedom from holes).
- Objective Laboratory Tests: For biocompatibility (primary skin irritation, delayed contact sensitization) and chemical analysis (USP iodine test for starch, measurement of water extractable protein).
8. The Sample Size for the Training Set
- Not Applicable: There is no "training set" for physical devices like these gloves. This concept is relevant for machine learning models.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As there is no training set, there is no ground truth, in the context of AI/ML, to be established for it.
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JUN -211 -599 MEDTEXX POWDER FREE LATEX EXAMINATION GLOVES
| Submitter's Name : | Medtexx Industries (Thai) Company Limited. |
|---|---|
| Submitter's Address : | 200 MU4, Tambun Tachaang, |
| Amphur Bangkam, 90110 | |
| Songkhla, Thailand. | |
| Submitter's Phone Number | 661 230 3606 |
| Submitter 's Fax Number : | 661 230 3606 |
| Name of Contact Person : | Steven Tan, Cheng Kim |
| Date of Preparation : | February 22, 1999 |
| Name of Device : | |
| Trade Name : | MEDTEXX POWDER FREE LATEX |
| EXAMINATION GLOVES | |
| Common Name : | Latex examination gloves |
| Classification Name : | Patient Examination Gloves |
| Legally Marketed Device to Which | MEDTEXX Powder Free Latex Examination |
| Equivalency is Being Claimed : | Gloves as described in the 510(k) notification are |
| substantially cquivalent to the Class 1 patient | |
| examination glove 80LYY. It meets all the | |
| current specifications listed under the ASTMSpecification D 3578 - 95, Standard Specification | |
| for Rubber Examination Gloves. | |
| Description of the Device : | MEDTEXX Powder Free Latex Examination |
| Gloves meet the current specifications listed | |
| under the ASTM Specification D 3578 95, | |
| Standard Specification for Rubber Examination | |
| Gloves. They are natural white in color and are | |
| powder free. | |
| Intended Use of the Device: | MEDTEXX Powder Free Latex Examination |
| Attachment 13 | |
| Gloves are intended for single use for medicalpurposes and are worn on the hand of health careand similar personnel to prevent contaminationbetween the health care personnel and thepatients. | |
| Summary of TechnologicalCharacteristics Compared to the PredicateDevice : | There are no different technologicalcharacteristics. Gloves are made from naturalrubber compound and the initial products arepowdered natural latex examination gloves.These gloves are then further processed intopowder free gloves using the existing technology,i.e. chlorinating and then washing the surfaces ofthe gloves. |
| Brief Discussion of Nonclinical Tests : | Testing is performed as per ASTM D 3578-95and 21 CFR 800.20. Gloves meet all the currentspecifications listed under the ASTMSpecification D 3578 - 95, Standard Specificationfor Rubber Examination Gloves.Primary skin irritation testing in the rabbit anddelayed contact sensitization testing in the guineapig indicate no irritation or sensitization.Final product is negative for the test for presenceof starch using the USP iodine test. |
| Brief Discussion of Clinical Tests : | No new clinical tests were conducted under this510(k). |
| Conclusions Drawn for the Nonclinicaland Clinical Tests : | Nonclinical laboratory and animal data indicatethat the powder free product meets allperformance and biocompatability requirements. |
| Other Information Deemed Necessary byFDA : | Not applicable |
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines forming the body and head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 1 1999
Mr. Stephen Tan Cheng Kim General Manager MedTexx Industries (Thai) Company Limited 200 MU-4, Tambol Tachang Amphur Bangklam, 90110 Songkhla, Thialand
Re : K991153 MedTexx Powder-Free Latex Examination Gloves Trade Name: Contains 50 Microgram or Less of Total Water Extractable Protein Per Gram Requlatory Class: I Product Code: LYY Dated: May 28, 1999 Received: June 4, 1999
Dear Mr. Stephen Tan Cheng Kim:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Stephen Tan Cheng Kim
this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note ens regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gpv/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Applicant
MEDTEXX INDUSTRIES (THAI) COMPANY LTD., MALAY SIA. 200 MU4, TAMBUN TACHAANG, AMPHUR BANGKAM, 90110 SONGKHLA, THAILAND.
| 510(k) Number (if known) | Kqa1153 |
|---|---|
| -------------------------- | --------- |
:
MEDTEXX POWDERFREE LATEX EXAMINATION Device Name : GLOVE (PROTEIN LABEL CLAIM) 50 Microgram or less of Total Water Extractable Protein per gram
Indications For Use :
Medtexx Powder free Latex Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Qiu S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospițal 510(k) Number
Prescription Use
§ 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.