(45 days)
Powdered 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 the healthcare personnel and the patient.
Powdered 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 powdered.
The device being discussed is "POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES".
Here's an analysis of the acceptance criteria and the study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The device is marketed as substantially equivalent to a Class I Patient Examination glove (product code 80LYY) and is required to meet the specifications of ASTM D 3578-05, Standard Specification for Rubber Examination Gloves, and 21 CFR 800.20.
| Acceptance Criteria (Standard / Regulation) | Reported Device Performance |
|---|---|
| ASTM D 3578-05 (Standard Specification for Rubber Examination Gloves) | Gloves meet "all the current specifications listed under the ASTM Specification D 3578-05". |
| 21 CFR 800.20 | Testing performed per 21 CFR 800.20, implying compliance. |
| Biocompatibility (Primary skin irritation) | "Primary skin irritation testing in the rabbit... indicate no irritation." |
| Biocompatibility (Delayed dermal contact sensitization) | "...delayed dermal contact sensitization study in the guinea pigs indicate no... sensitization." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the sample size used for the specific performance tests (e.g., tensile strength, elongation, barrier integrity as per ASTM D 3578-05). However, such standards typically specify sampling plans. For the biocompatibility tests:
- Primary skin irritation: Not specified, but generally a small number of rabbits are used (e.g., 3-6).
- Delayed dermal contact sensitization: Not specified, but generally a small number of guinea pigs are used (e.g., 10-20).
- Data Provenance (Country of Origin): The studies were likely conducted in Malaysia, as the submitter's address is Malaysia.
- Retrospective or Prospective: The non-clinical tests described were prospective studies specifically conducted for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable for a device like examination gloves. The "ground truth" for glove performance is established by objective measurements against engineering standards (ASTM D 3578-05) and biological response in animal models, not by expert interpretation.
4. Adjudication Method for the Test Set
This is not applicable as the "test set" involves objective measurements and animal studies, not human interpretation requiring adjudication.
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. This device is an examination glove, not an AI-powered diagnostic or assistive technology for human readers. Therefore, no MRMC comparative effectiveness study was performed.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. This device is an examination glove, not an algorithm or software. No standalone algorithm performance was assessed.
7. The Type of Ground Truth Used
- For performance characteristics (e.g., strength, dimensions, barrier integrity): The ground truth is defined by the objective measurement specifications and tolerances outlined in ASTM D 3578-05. For example, a glove "passes" if its tensile strength exceeds a specific value.
- For biocompatibility: The ground truth for irritation and sensitization is based on the observed biological reactions in the animal models according to established toxicological testing protocols. "No irritation or sensitization" is the ground truth observed against the control group or baseline.
8. The Sample Size for the Training Set
This is not applicable. Examination gloves are manufactured using established processes; there is no "training set" in the context of machine learning or AI involved in their development or validation. The manufacturing process itself is continually optimized, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set for this device in the context of the provided information.
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Attachment 17
K070821
510(k) SUMMARY
MAY 1 0 2007
POWDERED 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 | : POWDERED NATURAL RUBBER LATEXEXAMINATION GLOVES |
| Common Name | : Latex Examination Gloves |
| Classification Name | : Patient Examination Gloves |
| Legally Marketed Device to which Equivalency isBeing Claimed | Powdered Natural Rubber Latex ExaminationGloves as described 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 | Powdered Natural Rubber Latex ExaminationGlove is substantially equivalent to the Class 1patient examination glove bearing the productcode 80LYY ( 21 CFR 880.6250 ). It meets all the |
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| current 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 powdered. | |
|---|---|
| Intended Use of the Device | Powdered Natural Rubber Latex ExaminationGloves are intended for single use for medicalpurposes that is worn on the hand of health careand similar personnel to prevent contaminationbetween the health care personnel and thepatients. |
| 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 powderednatural rubber latex examination gloves. |
| Brief Description of Non-Clinical Tests | Testing performed per ASTMD 3578-05,Standard Specification for Rubber ExaminationGloves and 21 CFR 800.20. Gloves meet all thecurrent ASTM D 3578-05.Primary skin irritation testing in the rabbit anddelayed dermal contact sensitization study in theguinea pigs indicate no irritation or sensitization. |
| 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 test dataindicate that the powdered product meets allperformance and biocompatibility 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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring four human figures in profile, arranged in a stacked formation. The figures are connected and appear to be facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 0 2007
Mdm. Ooi Loon Seng Regulatory Affairs Manager Medtexx Manufacturing Sdn. Bhd. PT 4004 Kamunting Industrial Estate, Taiping Kamunting Perak, 34600 MALAYSIA
Re: K070821
Trade/Device Name: Powdered Natural Rubber Latex Examination Gloves (Protein Label Claim) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: March 23, 2007 Received: March 26, 2006
Dear Mdm. 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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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 (OS) 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suver Kune
Chin Lin, Ph.D.
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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INDICATIONS FOR USE
Applicant
MEDTEXX MANUFACTURING SDN. BHD. PT 4004, Kamunting Industrial Estate, 34600 Kamunting , Perak, Malaysia.
510(k) Number (if known)
070821
Device Name
POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM)
Indications For Use
Powdered 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 the healthcare personnel and the patient.
Concurrence of CDRH Office of Device Evaluation (ODE )
Prescription Use Per 21 CFR 801.109 OR Over-The-Counter
Shule V. Murphy Ko
Anestiiesiology, General Hospal,
Jon Control, Demal Devices
ck) Number: K/0 821
§ 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.