(54 days)
Powder Free Nitrile Examination Glove, Violet Color 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.
Powder Free Nitrile Examination Gloves, Violet Color meet the current ASTM Standard Specification for Nitrile Examination Gloves for Medical Application. It also meets all the current specifications listed under the ASTM Specification D 6913-00a Standard Specification for Nitrile Examination Gloves. They are violet in colour and are powder free.
The provided document is a 510(k) summary for POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR. This submission is for a medical device (examination gloves), not an AI/algorithm-driven device. Therefore, many of the requested elements for AI device evaluation are not applicable.
However, I can extract the information relevant to the acceptance criteria and the "study" (nonclinical tests) performed to demonstrate compliance for this type of device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard Reference) | Performance Demonstrated |
|---|---|
| ASTM D 6913-00a Standard Specification for Nitrile Examination Gloves for Medical Application | Gloves meet all current ASTM Standard Specification requirements for Nitrile Examination Gloves for Medical Application. |
| 21 CFR 800.20 (Quality System Regulation for Medical Devices: General) | Assumed compliance and verified through periodic QS inspections by FDA. |
| Primary skin irritation test (in rabbit) | No irritation. |
| Delayed contact sensitization test (in guinea pig) | No sensitization. |
| USP iodine test for starch | Negative for the presence of starch. |
| Biocompatibility requirements | Meets all. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for dimensions, tensile strength, etc., per ASTM D 6913-00a). It states "Testing performed per ASTM D 6913-00a" and "Primary skin irritation testing in the rabbit and delayed contact sensitization testing in the guinea pig."
- Test Set Sample Size: Not explicitly stated for each test, but implied to be sufficient to meet the requirements of the referenced ASTM standard and animal testing protocols.
- Data Provenance: Not explicitly stated as "country of origin," but the testing was performed for a Malaysian manufacturer, LATEXX MANUFACTURING SDN. BHD. The tests are non-clinical (laboratory and animal studies). Retrospective or prospective is not applicable in the context provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this type of device. "Ground truth" in the context of an AI device usually refers to expert-annotated data. For examination gloves, performance is assessed against established physical, chemical, and biological standards through laboratory and animal testing.
4. Adjudication method for the test set
Not applicable for this type of device. Performance is determined by standardized laboratory measurements and observations in animal models, not by human reader consensus on an "image" or "case."
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 not an AI-driven device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-driven device.
7. The type of ground truth used
The "ground truth" for this device's performance is based on well-established industry standards and scientific methods:
- Standard Specifications: Adherence to ASTM D 6913-00a for physical and performance characteristics of examination gloves.
- Established Biological Tests: Results from standardized primary skin irritation tests (in rabbits) and delayed contact sensitization tests (in guinea pigs).
- Chemical Tests: Results from the USP iodine test for starch.
8. The sample size for the training set
Not applicable. This is not an AI-driven device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI-driven device.
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POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR
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| K011791 510(K) SUMMARY | |
|---|---|
| Submitter's Name : | LATEXX MANUFACTURING SDN. BHD. |
| Submitter's Address : | PT 5054, Kamunting Industrial Estate |
| P.O. Box 9, 34600 Taiping, Perak | |
| AUG 1 2001 | Malaysia |
| Submitter's Phone Number | 605 891 1111 |
| Submitter 's Fax Number : | 605 891 1088 |
| Name of Contact Person : | Lim, Chian Chian |
| Date of Preparation : | May 2, 2001 |
| Name of Device : | |
| Trade Name : | POWDER FREE NITRILE EXAMINATION |
| GLOVES, VIOLET COLOR | |
| Common Name : | Nitrile examination gloves |
| Classification Name : | Patient Examination Gloves |
| Description of the Device : | Powder Free Nitrile Examination Gloves, Violet |
| Color meet the current ASTM StandardSpecification for Nitrile Examination Gloves for | |
| Medical Application. It also meets all the current | |
| specifications listed under the ASTMSpecification D 6913-00a Standard Specification | |
| for Nitrile Examination Gloves. They are violet in | |
| colour and are powder free. | |
| Intended Use of the Device: | Powder Free Nitrile Examination Gloves, Violet |
| Color are intended for single use 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 | |
| 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 performed per ASTM D 6913-00aNitrile Examination Gloves for MedicalApplication and 21 CFR 800.20. Gloves meet allthe current ASTM Standard Specification forNitrile Examination Gloves for MedicalApplication.Primary skin irritation testing in the rabbit anddelayed contact sensitization testing in the guineapig indicate no irritation of 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. |
| Other Information Deemed Necessary byFDA: | Not applicable. |
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Image /page/2/Picture/2 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of three human figures, one behind the other. The figures are connected at the shoulders and appear to be moving forward.
AUG 1 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Latexx Partners Bhd. C/O Ms. Christina Smith Consultant Smith Associates P.O. Box 4341 Crofton, Maryland 21114
Re : K011791 Powder Free Nitrile Examination Trade/Device Name: Gloves, Violet Color Requlation Number: 880.6250 Regulatory Class: I Product Code: LZA Dated: June 8, 2001 Received: June 8, 2001
Dear Ms. Smith:
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 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). 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 aqainst 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 requlations 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory
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Page 2 - Ms. Smith
In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does ents response or light on you might have under sections 531 through 542 of the Act for devices under the Electronic enroagn aadiation Control provisions, or other Federal laws or requlations.
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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Timothy M. Hlatowski
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
LATEXX MANUFACTURING SDN.BHD. PT 5054, Kamunting Industrial Estate P.O. Box 9 34600 Taiping Perak MALAY SIA
510(k) Number (if known)
Koil791 *
Device Name :
Indications For Use
POWDER FREE NITRILE EXAMINATION GLOVE, VIOLET COLOR
Powder Free Nitrile Examination Glove, Violet Color 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)
Clair S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 5 : 0(k) Number _
Prescription Use Per 21 CFR 801.109
OR Over-The-Counter
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§ 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.