(16 days)
HEALTH + AID ° PREMIUM Pre - Powdered Nitrile 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.
HEALTH + AID ® PREMIUM Pre - Powdered Nitrile Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 -- 95, Standard Specificatio for Rubber Examination Gloves. They are blu or natural white in colour.
The provided text describes a 510(k) summary for HEALTH + AID® PREMIUM PRE - POWDERED NITRILE EXAMINATION GLOVES. This document is a regulatory submission for a medical device (examination gloves) and focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study on an AI/ML powered device.
Therefore, many of the requested details, such as those related to AI/ML powered devices, ground truth, expert adjudication, multi-reader multi-case studies, and specific accuracy metrics, are not applicable or not present in this document.
However, I can extract information related to the acceptance criteria for these gloves and the nonclinical testing performed to meet those criteria.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM Specification D 3578 – 95 for Rubber Examination Gloves (EXCEPT for tensile strength and ultimate elongation) | Meets all current specifications listed under ASTM D 3578 – 95 (Standard Specification for Rubber Examination Gloves) |
| 21 CFR 800.20 (Quality System Regulation for Medical Devices) | Meets all current specifications listed under 21 CFR 800.20 (likely referring to general controls/requirements) |
| Primary skin irritation (in rabbit) | No irritation |
| Delayed contact sensitization (in guinea pig) | No sensitization |
| Presence of starch (USP iodine test) | Negative (no starch present) |
| Performance and biocompatibility requirements for pre-powdered nitrile product | Meets all performance and biocompatibility requirements |
Note: The document explicitly states that the device meets "all the current specifications listed under the ASTM Specification D 3578 – 95, Standard Specification for Rubber Examination Gloves," even though earlier text states the predicate device met D 3578-95 except for tensile strength and ultimate elongation. This suggests the new device is being compared against the full D 3578-95 standard, or the "EXCEPT" clause was hyper-specific to the predicate claim and not the current device's compliance. Given the "Brief Discussion of Nonclinical Tests" states "Gloves meet all the current specifications listed under the ASTM Specification D 3578 - 95," this is the performance claim.
Additional Information (as requested, but largely N/A for this document type):
2. Sample size used for the test set and the data provenance:
- Not applicable. This document describes nonclinical, physical, and biocompatibility testing of a physical product (gloves), not a software device or an AI/ML algorithm that would use a test set of data in the common sense. The testing is performed on samples of the manufactured gloves. The document does not specify sample sizes for these tests, nor data provenance in terms of country of origin for a data set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in the context of expert consensus is not relevant here. The ground truth for glove performance is defined by standardized test methods (e.g., ASTM D 3578-95) and the objective measurements derived from them. Biocompatibility tests are performed by qualified laboratories and personnel following established protocols, but the concept of "experts establishing ground truth for a test set" like in AI/ML is not applicable.
4. Adjudication method for the test set:
- Not applicable. This concept relates to conflicting interpretations from multiple experts on a diagnostic image or data point. For physical product testing as described, the results are typically quantitative measurements that either pass or fail a predefined limit.
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 a physical product (examination gloves), not an AI-powered diagnostic device. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical product (examination gloves), not an algorithm or software.
7. The type of ground truth used:
- For physical properties and barrier integrity: Objective measurements against ASTM standards.
- For biocompatibility: Animal study results (irritation, sensitization) and chemical tests (starch presence). These are considered direct evidence of the device's properties as per regulatory guidelines at the time.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of an AI/ML algorithm for this device. The manufacturing process itself (and quality control checks on manufactured batches) could be seen as analogous to continuous learning and validation, but not in the AI/ML sense.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
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510(k) SUMMARY
MAY 2 8 1929
HEALTH + AID ® PREMIUM PRE - POWDERED NITRILE 1991640 EXAMINATION GLOVES
| Submitter's Name : | M.R.G. INDUSTRIES SDN. BHD. |
|---|---|
| Submitter's Address : | PT 4004, Kamunting Industrial Estate, |
| 34600 Taiping Perak | |
| Malaysia | |
| Submitter's Phone Number | 605 891 1111 |
| Submitter 's Fax Number : | 605 891 1088 |
| Name of Contact Person : | Lim, Chong Eng |
| Date of Preparation : | April 27, 1999 |
| Name of Device : | |
| Trade Name : | HEALTH + AID ® PREMIUM PRE –POWDERED NITRILE EXAMINATIONGLOVES |
| Common Name | Nitrile examination gloves |
| Classification Name : | Patient Examination Gloves |
| Legally Marketed Device to WhichEquivalency is Being Claimed : | HEALTH + AID ® PREMIUM Pre – PowderedNitrile Examination Gloves as described in the510(k) notification are substantially equivalent tothe Class 1 patient examination glove (Nitrile)80LZA, that meets the current draft ASTMStandard Specification for Nitrile ExaminationGloves for Medical Application. It also meets allthe current specifications listed under the ASTMSpecification D 3578 – 95, Standard Specificationfor Rubber Examination Gloves, EXCEPT fortensile strength and ultimate elongation. |
| Description of the Device : | HEALTH + AID ® PREMIUM Pre - PowderedNitrile Examination Gloves meet the currentspecifications listed under the ASTMSpecification D 3578 -- 95, Standard Specificatiofor Rubber Examination Gloves. They are bluor natural white in colour. |
| Intended Use of the Device: | HEALTH + AID ® PREMIUM Pre - PowderedNitrile Examination Gloves are intended fosingle use for medical purposes and are worn othe hand of health care and similar personnel tprevent contamination between the health carpersonnel and the patients. |
| Summary of TechnologicalCharacteristics Compared to the PredicateDevice : | There are no different technologicalcharacteristics. Gloves are made from nitrilrubber compound and the initial products anpowdered nitrile latex examination 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 Specificatiofor Nitrile Examination Gloves.Primary skin irritation testing in the rabbit andelayed contact sensitization testing in the guineapig indicate no irritation or sensitization.Final product is negative for the test for presencof starch using the USP iodine test. |
| Brief Discussion of Clinical Tests : | No new clinical tests were conducted under thi510(k). |
| Conclusions Drawn for the Nonclinicaland Clinical Tests : | Nonclinical laboratory and animal data indicatthat the pre- powdered nitrile product meets aperformance and biocompatability requirements. |
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Attachment 15
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| Other Information Deemed Necessary by |
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| FDA : |
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: . ・ . Not applicable
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 8 1999
Mr. Chonq Eng Lim General Manaqer MRG Industries Sdn. Bhd. PT 4004, Kamunting Industrial Estate P.O. Box 9 34600 Kamunting, Taiping, Perak, MALAYSIA
Re : K991640 Health + Aid® Premium Nitrile Exam Gloves Trade Name: Requlatory Class: I Product Code: LZA Dated: May 5, 1999 Received: May 12, 1999
Dear Mr. Chong Eng Lim:
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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification 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.
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Page 2 - Mr. Chong Eng Lim
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 the 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.gov/cdrh/dsmamain.html".
Sincerely yours, unive SULSAN
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
M.R.G. INDUSTRIES SDN. BHD. Applicant PT 4004, Kamunting Industrial Estate P.O. Box 9 34600 Taiping Perak MALAYSIA
来 Kag1640 510(k) Number : (if known)
HEALTH + AID PREMIUM PRE - POWDERED Device Name : NITRILE EXAMINATION GLOVES
Indications For Use :
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HEALTH + AID ° PREMIUM Pre - Powdered Nitrile 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)
Clim S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Prescription Use Per 21 CFR 801.109 OR Over-The-Counter
§ 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.