(66 days)
Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove is substantially equivalent to the Class 1 patient examination glove bearing the product code 80LYY ( 21 CFR 880.6250 ). It meets all the current specifications listed under the ASTM Specification D-3578-05, Standard Specification for Rubber Examination Gloves. They are made from natural rubber latex. They are natural white in color and are powder free.
The provided document is a 510(k) summary for "NON-CHLORINATED, POLYMER COATED, POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES." This pertains to a medical device (examination gloves) and not a software algorithm. Therefore, many of the questions asked about acceptance criteria and study design for software performance are not directly applicable.
However, I can extract the information that is relevant to the "acceptance criteria" and the "study that proves the device meets the acceptance criteria" for this physical device.
Here's the breakdown based on the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard Specification) | Reported Device Performance |
|---|---|
| ASTM D 3578-05, Standard Specification for Rubber Examination Gloves | "Gloves meet all the current ASTM D 3578-05 requirements." |
| 21 CFR 800.20 (Biocompatibility) | "Primary skin irritation testing... indicate no irritation or sensitization." |
| Presence of Starch | "Final product has been tested negative for the presence of starch using the USP iodine test." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for the non-clinical tests. The tests were performed by MEDTEXX MANUFACTURING SDN. BHD. in Malaysia. These were non-clinical (laboratory and animal-based) tests, presumably prospective as they were conducted 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 question is not applicable. The device is evaluated against engineering standards (ASTM D 3578-05) and regulatory guidelines (21 CFR 800.20) for material properties and biocompatibility. There is no concept of "expert ground truth" in the diagnostic sense for this type of device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical studies involving interpretation of medical images or data by multiple experts. For physical device testing against standards, the results are typically objectively measured and compared to predefined thresholds.
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 question is not applicable. MRMC studies and the concept of AI assistance are related to diagnostic software or tools that aid human interpretation. This document describes a physical medical device (examination gloves), not a diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical product, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is defined by:
- ASTM D 3578-05 Standard: This standard specifies physical properties such as tensile strength, elongation, and dimensions for rubber examination gloves.
- 21 CFR 800.20: This regulation outlines biocompatibility requirements, which are assessed through tests like primary skin irritation and delayed contact sensitization.
- USP iodine test: Used to determine the absence of starch.
These are objective, measurable standards, not observational or interpretive ground truth established by experts in a clinical context.
8. The sample size for the training set
This question is not applicable. The concept of a "training set" applies to machine learning algorithms. This document describes the testing of a physical product against established engineering and biocompatibility standards.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as above. There is no training set for this type of device.
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Attachment 13
510(k) SUMMARY
MAR 1 5 2007
NON-CHLORINATED, POLYMER COATED, POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES
| Submitter's Name | MEDTEXX MANUFACTURING SDN. BHD. |
|---|---|
| Submitter's Address | PT 4004, Kamunting Industrial Estate34600 Taiping, Perak,Malaysia |
| Submitter's Phone Number | 605-891 1111 / 605-891 5555 |
| Submitter's Fax Number | 605-891 1088 |
| Name of Contact Person | Ooi Loon Seng |
| Date of Preparation | |
| Name of Device | |
| Trade Name | : NON-CHLORINATED, POLYMER COATED,POWDER FREE NATURAL RUBBER LATEXEXAMINATION GLOVES |
| Common Name | : Latex Examination Gloves |
| Classification Name | : Patient Examination Gloves |
| Legally Marketed Device to which Equivalency isBeing Claimed | Non-Chlorinated, Polymer Coated, Powder FreeNatural Rubber Latex Examination Gloves asdescribed in this 510 K Notification issubstantially equivalent to the current Class 1Patient Examination Glove bearing the productcode 80LYY ( 21 CFR 880.6250 ). It meets all thecurrent specifications listed under the ASTMSpecification D 3578-05, Standard Specificationfor Rubber Examination Gloves. |
| Description of the Device | Non-Chlorinated, Polymer Coated, Powder FreeNatural Rubber Latex Examination Glove issubstantially equivalent to the Class 1 patientexamination glove bearing the product code80LYY ( 21 CFR 880.6250 ). It meets all thecurrent specifications listed under the ASTMSpecification D-3578-05, Standard Specificationfor Rubber Examination Gloves. They are madefrom natural rubber latex. They are natural whitein color and are powder free. |
| Intended Use of the Device | Non-Chlorinated, Polymer Coated, Powder FreeNatural Rubber Latex Examination Gloves areintended for single use for medical purposes thatis worn on the hand of health care and similarpersonnel to prevent contamination between thehealth care personnel and the patients. |
| Summary of Technological CharacteristicCompared to the Predicate Device | There is no different technological characteristic.Gloves are made from natural rubber latexcompound and the initial products are lowpowdered natural rubber latex gloves. Thesegloves are using the existing technology, i.e.multiple washing and rinsing processes. |
| Brief Description of Non-Clinical Tests | Testing were performed per ASTM D 3578-05,Standard Specification for Rubber ExaminationGloves and 21 CFR 800.20. Gloves meet all thecurrent ASTM D 3578-05 requirements.Primary skin irritation testing in the rabbit anddelayed contact sensitization testing in theguinea pig indicate no irritation or sensitization.Final product has been tested negative for thepresence of starch using the USP iodine test. |
| Brief description of Clinical Tests | No new clinical tests were conducted under this510(k). |
| Conclusions Drawn from the Non-Clinical andClinical Tests | Non-Clinical laboratory and animal based testdata indicate that the powder free product meetsall performance and biocompatibilityrequirements. |
| Other Information Deemed Necessary by FDA | Not Applicable. |
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes forming its wings, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a simple, official emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ooi Loon Seng Regulatory Affairs Manager MEDTEXX Manufacturing Sdn. Bhd. PT 4004 Kamunting Industrial Estate, 34600 Taiping Perak MALAYSIA
MAR 1 5 2007
Re: K070072
Trade/Device Name: Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: February 28, 2007 Received: March 5, 2007
Dear Ms. Seng:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Seng
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Syndie y. Michael Dmd.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Non-Chlorinated Polymer Coated Powder Free Natural Rubber Latex Examination Gloves
Attachment 2
INDICATIONS FOR USE
Applicant
MEDTEXX MANUFACTURING SDN. BHD. PT 4004, Kamunting Industrial Estate, 34600 Kamunting , Perak, Malaysia.
510(k) Number (if known)
070072 *
Device Name
NON-CHORINATED, POLYMER COATED, POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVE
Indications For Use
Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Concurrence of CDRH Office of Device Evaluation (ODE )
| Prescription Use | OR Over-The-Counter X |
|---|---|
| Per 21 CFR 801.109 |
Carrier Company
100 2017
§ 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.