(68 days)
HEALTH + AID PREMIUM Powderfree Nitrike 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 Powder Free Nitrile Examination Gloves meet all the current specification listed under the ASTM Specification Examination Gloves, EXCEPT for ultimate elongation before ageing. They are blue or natural white in colour and are powder free.
Here's an analysis of the provided text regarding the acceptance criteria and study for the "HEALTH + AID® PREMIUM POWDER FREE NITRILE EXAMINATION GLOVES."
It's important to note that this document is a 510(k) summary for a medical glove, which is a relatively low-risk device. As such, the type of studies and acceptance criteria are vastly different from what would be expected for a complex AI/ML-driven diagnostic device. Many of the questions you asked are geared towards AI/ML devices and therefore will not be fully answerable from this submission.
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Set by ASTM D 3578-95) | Reported Device Performance (HEALTH + AID® PREMIUM Powder Free Nitrile Examination Gloves) | Notes |
|---|---|---|
| Specific parameters of ASTM D 3578-95 | Meets all current specifications listed under ASTM D 3578-95, EXCEPT for ultimate elongation before ageing. | The specific values for each parameter from ASTM D 3578-95 are not provided in this summary, nor are the exact performance values of the device. However, a general statement of compliance (with one exception) is given. |
| Primary skin irritation (rabbit) | Indicates no irritation | Biocompatibility testing. |
| Delayed contact sensitization (guinea pig) | Indicates no sensitization | Biocompatibility testing. |
| Absence of starch | Negative for the presence of starch using the USP iodine test | Relevant for powder-free claims. |
Missing Information (Due to device type): For medical gloves, the primary "acceptance criteria" revolve around physical properties (e.g., tensile strength, elongation, barrier integrity) defined by consensus standards like ASTM D 3578-95, rather than diagnostic accuracy metrics (sensitivity, specificity, AUC) seen in AI/ML devices. The specific numerical targets for ASTM D 3578-95 and the device's actual performance values against those targets are not detailed in this summary.
Study Details (Applicable to this device type)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Physical/Chemical Tests: The document states "Testing is performed as per ASTM D 3578-95 and 21 CFR 800.20." These standards specify sampling plans for testing. However, the specific number of gloves tested (sample size) for each physical property (e.g., tensile strength, elongation, freedom from holes) is not explicitly stated in this 510(k) summary.
- Data Provenance: Not explicitly stated, but typically these tests would be conducted by the manufacturer or a contracted lab. Given the submitter's address (Malaysia), it's highly probable the testing occurred there. These would be considered prospective tests performed on batches of the manufactured product.
- Sample Size for Biocompatibility Tests: For primary skin irritation and delayed contact sensitization tests:
- Primary skin irritation: Conducted in the rabbit. Typical sample sizes for such tests involve a small number of animals (e.g., 3-6 rabbits). The exact number is not specified.
- Delayed contact sensitization: Conducted in the guinea pig. Typical sample sizes for such tests involve a small number of animals (e.g., 10-20 guinea pigs for the test group, plus controls). The exact number is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable (N/A). For medical gloves, "ground truth" is established by adherence to physical, chemical, and biological performance standards (e.g., tensile strength values, absence of irritants). This is measured objectively by laboratory equipment and standard protocols, not by expert interpretation in the same way as an image-based diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for human expert consensus in diagnostic studies (e.g., reviewing medical images). For medical gloves, performance is measured objectively against predefined specifications, not through expert consensus on qualitative observations.
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 (N/A). This device is a nitrile examination glove, not an AI/ML diagnostic system intended to assist human readers. Therefore, an MRMC study and effect size in the context of AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable (N/A). This device is a physical product (a glove), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for these gloves is defined by:
- Standard Specifications: Adherence to the physical performance requirements outlined in ASTM D 3578-95 (e.g., tensile strength, elongation, freedom from holes, dimensions). These are objective, measurable criteria.
- Biocompatibility Standards: Results from established animal models for irritation and sensitization.
- Chemical Tests: Specific tests like the USP iodine test for starch presence.
8. The sample size for the training set
- Not applicable (N/A). This device does not use machine learning, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable (N/A). This device does not use machine learning, so there is no "training set" and thus no ground truth to establish for it in this context.
{0}------------------------------------------------
510(k) SUMMARY
JUN 2:3 1999
HEALTH + AID® PREMIUM POWDER FREE NITRILE EXAMINATION GLOVES
| Submitter's Name : | M.R.G.Industries Sdn. Bhd. |
|---|---|
| Submitter's Address : | PT 4004, Kamunting Industrial Estate34600 Taiping PerakMalaysia |
| Submitter's Phone Number | 605 891 1111 |
| Submitter 's Fax Number : | 605 891 1088 |
| Name of Contact Person : | Lim, Chong Eng |
| Date of Preparation : | May 15,1999 |
| Name of Device : | |
| Trade Name : | HEALTH + AID® PREMIUM POWDER FREENITRILE EXAMINATION GLOVES |
| Common Name : | Nitrile examination gloves |
| Classification Name : | Patient Examination Gloves |
| Legally Marketed Device to WhichEquivalency is Being Claimed : | HEALTH + AID® PREMIUM Powder FreeNitrile Examination Gloves as described in the510(k) notification are substantially equivalent tothe Class 1 patient examination glove (Nitrile)80LZA, that meets all the current specificationslisted under the ASTM Specification D 3578 -95, Standard Specification for RubberExamination Gloves, EXCEPT for ultimateelongation before ageing.. |
| Description of the Device : | HEALTH + AID® PREMIUM Powder FreeNitrile Examination Gloves meet all the currentspecification listed under the ASTM Specification |
| Examination Gloves, EXCEPT for ultimateelongation before ageing. They are blue ornatural white in colour and are powder free. | |
| Intended Use of the Device: | HEALTH AID ® PREMIUM Powder FreeNitrile Examination Gloves are intended forsingle use for medical purposes that is worn onthe hand of health care and similar personnel toprevent contamination between the health carepersonnel and the patients. |
| Summary of TechnologicalCharacteristics Compared to the PredicateDevice : | There is no different technological characteristics.Gloves are made from nitrile rubber compoundand the initial products are powdered nitrilerubber gloves. These gloves are then furtherprocessed into powder free gloves using theexisting technology, i.e. washing and thenchlorinating the surfaces of the gloves. |
| Brief Discussion of Nonclinical Tests : | Testing is performed as per ASTM D 3578-95and 21 CFR 800.20. Gloves meet the currentASTM D 3578 - 95 Standard Specification forRubber Examination Gloves, EXCEPT forultimate elongation before ageing.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 presence ofstarch 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. |
{1}------------------------------------------------
{2}------------------------------------------------
| Other Information Deemed Necessary by FDA : | Not applicable |
|---|---|
| --------------------------------------------- | ---------------- |
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle.
Public Health Service
JUN 23 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Chong Eng Lim General Manager M.R.G. Industries Sdn. Bhd. PT4004, Kamunting Industrial Estate P.O. Box 9, 34600 Kamuntinq Taiping, Perak MALAYSIA
Re: K991304 Health + Aid® Premium Powder Free Blue Trade Name: Nitrile Examination Gloves Requlatory Class: 】 Product Code: LZA Dated: April 3, 1999 Received: April 16, 1999
Dear Mr. Chonq 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 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 (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 regulation may result in regulatory action. In
{4}------------------------------------------------
Page 2 - Mr. Chong Eng Lim
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 regulation (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
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
INDICATIONS FOR USE
Applicant
:
:
M.R.G. INDUSTRIES SDN. BHD. PT 4004, Kamunting Industrial Estate P.O. Box 9 34600 Taiping Perak MALAYSIA
K991304 *
510(k) Number (if known)
Device Name
HEALTH + AID PREMIUM POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
Indications For Use
HEALTH + AID PREMIUM Powderfree Nitrike 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)
| Prescription UsePer 21 CFR 801.109 | |
|---|---|
| OR | Over-The-CounterX |
| (Division Sign-Off) | |
| Division of Dental, Infection Control,and General Hospital Devices |
§ 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.