(66 days)
HEALTH + AID @ PREMIUM Powderfree 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 contanination between the health care personnel and the patient.
HEALTH + AID ® PREMIUM 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 colour and are powder free.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the "HEALTH + AID ® PREMIUM POWDER FREE LATEX EXAMINATION GLOVES":
This document is a 510(k) summary for a medical device (examination gloves), which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed performance study with comprehensive acceptance criteria and statistical analysis of an AI algorithm. Therefore, many of the requested points related to AI performance, expert ground truth, adjudication, MRMC studies, and training sets are not applicable to this type of submission.
The "acceptance criteria" for this device are the established specifications for latex examination gloves, primarily defined by the ASTM D 3578-95 standard and FDA regulations.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ASTM D 3578-95 & 21 CFR 800.20) | Reported Device Performance |
|---|---|
| Physical Properties (e.g., Tensile Strength, Elongation, Dimensions, Freedom from Holes) | "Gloves meet all the current specifications listed under the ASTM Specification D 3578-95, Standard Specification for Rubber Examination Gloves." |
| Biocompatibility (e.g., Primary Skin Irritation, Delayed Contact Sensitization) | "Primary skin irritation testing in the rabbit and delayed contact sensitization testing in the guinea pig indicate no irritation or sensitization." |
| Powder/Starch Content | "Final product is negative for the test for presence of starch using the USP iodine test." |
| Protein Content | "With Protein Labeling Claim (50 Micrograms or Less)" / "50 MICROGRAMS OR LESS OF TOTAL EXTRACTABLE PROTEIN PER GRAM." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of an AI algorithm's performance evaluation. Instead, it refers to general product testing in accordance with established standards.
- Sample Size: Not explicitly stated for specific tests. ASTM D 3578-95 and 21 CFR 800.20 would dictate the sampling plans and lot sizes required for various tests (e.g., visual inspection for holes, physical properties, bioburden).
- Data Provenance: The testing was performed on the manufactured "HEALTH + AID ® PREMIUM POWDER FREE LATEX EXAMINATION GLOVES" themselves, presumably at the manufacturer's facility (M.R.G. INDUSTRIES SDN. BIID., Malaysia) or by a contracted lab. This would be considered prospective for the specific batches tested to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This concept is not applicable to this device and submission. "Ground truth" in this context refers to established laboratory testing methods and regulatory standards, not expert consensus on medical images or clinical observations. The "experts" would be the laboratory technicians performing the specified tests according to ASTM and FDA protocols, who are qualified in those specific testing methodologies.
4. Adjudication Method for the Test Set
This concept is not applicable. Adjudication refers to resolving disagreements among experts, which isn't relevant for standardized laboratory tests against predefined specifications.
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
This is not applicable as this is not an AI-powered diagnostic or assistive device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as this is not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Standardized Laboratory Test Results: Measurements of physical properties (tensile strength, elongation, etc.), chemical tests (starch presence, protein content), and biological tests (skin irritation, sensitization) performed according to internationally recognized standards like ASTM D 3578-95 and specified methodologies in 21 CFR 800.20.
- Predicate Device Equivalence: The primary "ground truth" for regulatory acceptance is demonstrating that the device is "substantially equivalent" to an already legally marketed device (Class 1 patient examination glove 80LYY which meets ASTM D 3578-95).
8. The Sample Size for the Training Set
This is not applicable as this is not an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as this is not an AI algorithm.
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JUN 2 1 1999
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510(k) SUMMARY K 99/30S
HEALTH + AID ® PREMIUM POWDER FREF LATEX EXAMINATION GLOVES
| Submitter's Name : | M.R.G. INDUSTRIES SDN. BIID. | |
|---|---|---|
| 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 : | March 31, 1999 | |
| Name of Device : | ||
| Trade Name : | HEALTH + AID ® PREMIUM POWDER FREELATEX EXAMINATION GLOVES | |
| Common Name | Latex examination gloves | |
| Classification Name : | Patient Examination Gloves | |
| Legally Marketed Device to WhichEquivalency is Being Claimed : | HEALTH + AID ® PREMIUM Powder FreeLatex Examination Gloves as described in the510(k) notification are substantially equivalent tothe Class 1 patient examination glove 80LYY. Itmeets all the current specifications listed underthe ASTM Specification D 3578 - 95, StandardSpecification for Rubber Examination Gloves. | |
| Description of the Device : | HEALTH + AID ® PREMIUM Powder FreeLatex Examination Gloves meet the currentspecifications listed under the ASTMSpecification D 3578 - 95, Standard Specificationfor Rubber Examination Gloves. They arenatural white in colour and are powder free. | |
| Intended Use of the Device: | HEALTH + AID ® PREMIUM Powder Frec | |
| Latex Examination Gloves are intended for singleuse for medical purposes and are worn on thehand of health care and similar personnel toprevent contamination between the health carepersonnel and the patients. | ||
| 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 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 right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 1 1999
Mr. Chonq Eng Lim General Manager M.R.G. Industries Sdn. Bhd. PT4004, Kamunting Industrial Estate P.O. Box 9, 34600 Kamunting Taipinq, Perak MALAYSIA
Re : K991305 Health + Aid® Premium Powder Free Latex Trade Name: Examination Gloves With Protein Labeling Claim (50 Micrograms or Less) Regulatory Class: I Product Code: LYY March 31, 1999 Dated: Received: April 16, 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
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Page 2 - Mr. Chong Eng Lim
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.
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 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,
Timothy A. Ulatowski
Directør 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
M.R.G. INDUSTRIES SDN. BHD. PT 4004, Kamunting Industrial Estate P.O. Box 9 34600 Taiping Perak MALAYSIA
510(k) Number (if known)
K991305 *
HEALTH + AID® PREMIUM POWDER FREE LATEX Device Name EXAMINATION GLOVE (PROTEIN LABEL CLAIM) 50 MICROGRAMS OR LESS OF TOTAL EXTRACTABLE PROTEIN PER GRAM.
Indications For Use
HEALTH + AID @ PREMIUM Powderfree 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 contanination 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)
Quis S. Lin
(Division Sign-Off Division of Dental, Infection Control, and General Hospit 1: ' O/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.