(54 days)
Powder Free Nitrile Examination Glove, Blue Color is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
Non-chlorinated, Polymer Coated, Powder Free Nitrile Examination Gloves, Blue 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 6319-00a, Standard Specification for Nitrile Examination Gloves. They are blue in colour and are powder free.
The provided text is for a 510(k) summary for "NON-CHLORINATED, POLYMER COATED, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE COLOR". This document describes the device and its compliance with established standards, but it does not contain information related to an AI/ML device. Therefore, many of the requested points regarding AI/ML device performance and testing (e.g., effect size of human readers with AI, standalone algorithm performance, training set details) are not applicable.
Here's an analysis based on the information provided for the nitrile examination gloves:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from ASTM D 6319-00a and 21 CFR 800.20) | Reported Device Performance |
|---|---|
| Physical Performance: Meets ASTM D 6319-00a | "Gloves meet all the current ASTM Standard Specification for Nitrile Examination Gloves for Medical Application." (Referring to ASTM D 6319-00a) |
| Pinhole/Leakage (21 CFR 800.20): Not explicitly stated but implied by ASTM compliance | Not explicitly detailed, but compliance with ASTM D 6319-00a would include limits on pinholes/water leakage. |
| Biocompatibility (Primary Skin Irritation): No irritation | "Primary skin irritation testing in the rabbit... indicate no irritation." |
| Biocompatibility (Delayed Contact Sensitization): No sensitization | "delayed contact sensitization testing in the guinea pig indicate no... sensitization." |
| Powder-Free Requirement: Absence of starch | "Final product is negative for the presence of starch using the USP iodine test." |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test mentioned (e.g., number of gloves tested for physical properties, number of animals for biocompatibility). The provenance of the data is that the tests were performed by the manufacturer, LATEXX MANUFACTURING SDN. BHD., based in Malaysia. The studies were non-clinical (laboratory and animal-based) and are presented as retrospective data to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as this is a non-AI/ML device submission for examination gloves. The "ground truth" is established by the specifications defined in ASTM D 6319-00a and 21 CFR 800.20, which are consensus standards and regulations.
4. Adjudication method for the test set
Not applicable for this type of device and testing. Test results are compared directly against established standard 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
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The ground truth is based on established industry standards and regulatory requirements, specifically:
- ASTM D 6319-00a (Standard Specification for Nitrile Examination Gloves for Medical Application)
- 21 CFR 800.20 (Pinhole Barrier Integrity)
- USP iodine test (for absence of starch)
- Standard methods for biocompatibility testing (skin irritation and sensitization in animal models).
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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<011792
510(k) SUMMARY
AUG 1 2001
NON-CHLORINATED, POLYMER COATED, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE COLOR
| Submitter's Name | LATEXX MANUFACTURING SDN. BHD. |
|---|---|
| Submitter's Address | PT 5054, Kamunting Industrial Estate |
| P.O. Box 9, 34600 Taiping, Perak | |
| Malaysia | |
| Submitter's Phone Number | 605 891 1111 |
| Submitter 's Fax Number | 605 891 1088 |
| Name of Contact Person | Teoh, Choh Shee |
| Date of Preparation | May 12, 2001 |
| Name of Device | |
| Trade Name | NON-CHLORINATED, POLYMER COATED,POWDER FREE NITRILE EXAMINATION GLOVES,BLUE COLOR |
| Common Name | Nitrile examination gloves |
| Classification Name | Patient Examination Gloves |
| Description of the Device | Non-chlorinated, Polymer Coated, Powder Free NitrileExamination Gloves, Blue Color meet the currentASTM Standard Specification for Nitrile ExaminationGloves for Medical Application. It also meets all thecurrent specifications listed under the ASTMSpecification D 6319-00a, Standard Specification forNitrile Examination Gloves. They are blue in colourand are powder free. |
| Intended Use of the Device | Non-chlorinated, Polymer Coated, Powder Free NitrileExamination Gloves, Blue Color are intended forsingle use for medical purposes that is worn on thehand of health care and similar personnel to preventcontamination between the health care personnel andthe patients. |
| Summary of Technological Characteristicscompared to the Predicate Device | There is no different technological characteristic.Gloves are made from nitrile rubber compound andthe initial products are powdered Nitrile rubber gloves.These gloves are then further processed into powderfree gloves using the existing technology, i.e. washingprocess. |
| Brief Discussion of Non-clinical Tests | Testing performed per ASTM D 6319-00a NitrileExamination Gloves for Medical Application and 21CFR 800.20. Gloves meet all the current ASTMStandard Specification for Nitrile Examination Glovesfor Medical Application.Primary skin irritation testing in the rabbit and delayedcontact sensitization testing in the guinea pig indicateno irritation of sensitization.Final product is negative for the presence of starchusing the USP iodine test. |
| Brief Discussion of Clinical Tests | No new clinical tests were conducted under this510(k). |
| Conclusions Drawn for the Non-clinical andClinical Tests | Non-clinical laboratory and animal based test dataindicate that the powder-free product meets allperformance and biocompatability requirements. |
| Other Information Deemed Necessary by FDA | 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 symbol that resembles three abstract shapes, possibly representing human figures or waves.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 2001
Latexx Partners Bhd. C/O Ms. Christina Smith Consultant Smith Associates P.O. Box 4341 Crofton, Maryland 21114
Re : K011792 Trade/Device Name: Non-Chlorinated, Polymer Coated Powder-Free Nitrile Examination Gloves 880.6250 Requlation Number: Regulatory Class: I Product Code: LZA Dated: June 8, 2001 June 8, 2001 Received:
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 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 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 requlation 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 on fight on 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 marketed produces overmits 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" (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,
Clulalorst
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 EstateP.O. Box 934600 Taiping PerakMALAYSIA |
|---|---|
| 510(k) Number (if known) | K011792 * |
| Device Name | NON-CHLORINATED, POLYMER COATED,POWDER FREE NITRILE EXAMINATION GLOVE,BLUE COLOR |
Indications For Use
Powder Free Nitrile Examination Glove, Blue Color is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
Concurrence of CDRH Office of Device Evaluation (ODE)
Chiu S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 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.