(176 days)
Blue Powder Free Latex Examination Gloves, Non-Sterile is a disposable medical device made from natural rubber latex compound. It is intended to be worn on the hands as a barrier against potentially infectious materials and other contamination.
Latex Patient Examination Gloves, LYY, Powder Free
The provided text describes a 510(k) submission for Blue Powder Free Latex Examination Gloves, Non-Sterile. This submission focuses on medical gloves, which are physical products, not an AI/ML powered device. As such, the concept of "acceptance criteria" and "study" in the context of an AI/ML device's performance metrics (like accuracy, sensitivity, specificity, sample sizes for training/test sets, ground truth establishment, expert adjudication, MRMC studies, or standalone performance) is not applicable here.
The document primarily addresses the glove's compliance with established industry standards and FDA requirements for medical devices, specifically patient examination gloves.
Here's a breakdown of the relevant information provided, adapted to the context of a medical glove:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that the device "meets ASTM D 3578-01 Standard and FDA's requirement" for quality performance. It also states the device "pass the Biocompatibility Test." Specific numerical performance metrics (like AQL levels for pinholes) are not detailed in this excerpt but would be part of the underlying test reports.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Quality Performance | Meets ASTM D 3578-01 Standard and FDA's requirement |
| Biocompatibility | Pass the Biocompatibility Test (Primary Dermal Irritation Study And the Dermal Sensitization Study) |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in the provided text for the quality performance or biocompatibility tests. These would typically be specified in the full test reports referenced by the 510(k) submission.
- Data Provenance: The manufacturing entity is MultiSafe Sdn. Bhd. located in Malaysia. The testing would have been conducted to meet US FDA requirements and international standards (ASTM D 3578, ISO 11193, EN 455). The origin of the raw data/samples tested would be from the manufacturing process in Malaysia.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not applicable for a medical glove submission. Ground truth for a physical medical device like a glove is established through adherence to standardized physical, chemical, and biological testing protocols, not expert consensus on interpretations.
4. Adjudication method for the test set:
This concept is not applicable for a medical glove submission. Adjudication is relevant for diagnostic interpretations, not for physical product testing against standardized 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:
This concept is not applicable as this is a medical glove, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This concept is not applicable as this is a medical glove, not an algorithm.
7. The type of ground truth used:
For a medical glove, the "ground truth" is defined by:
- Standardized Physical and Performance Specifications: E.g., ASTM D 3578-01 for dimensions, tensile strength, elongation, and barrier integrity (absence of pinholes at specified AQL levels).
- Biocompatibility Standards: Absence of irritation or sensitization as determined by standardized in-vivo (animal or human patch) tests.
- Chemical Properties: Compliance with limits for extractable proteins (for latex gloves) if applicable.
8. The sample size for the training set:
This concept is not applicable as this is a medical glove. There is no "training set" in the context of an AI/ML algorithm. The "training" for glove manufacturing would refer to process control and quality system implementation.
9. How the ground truth for the training set was established:
This concept is not applicable as this is a medical glove.
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17.0 SMDA 510(K) SUMMARY
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FEB 2 0 2007
| 1. Applicant | MULTISAFE SDN. BHDLot 764, Bidor Industrial Estates,35500 Bidor,Perak Darul Ridzuan,Malaysia. |
|---|---|
| Tel No. | 605-4348269 |
| Fax No | 605-4348266 |
| Name of Contact Person | 1. Mr. Abd Hadi bin Husin2. Ms. Rosnani Binti Hassan Besari |
| Date of Summary Prepared | 10th August 2006 |
| 2. Name of Device | |
| Trade Name | Blue Powder Free Latex ExaminationGlove, Non-Sterile |
| Common Name | Examination Gloves |
| Classification Name | Patient Examination Gloves (Class 1 inUS and European markets, Class IIa inCanadian Market) |
3. Identification Of the Legally Marketed Devices
Latex Patient Examination Gloves LYY, Powder Free that meets all the requirements of FDA, ASTM D 3578, ISO 11193, EN 455 : Part 1, Part 2 and Part 3, CMDR, MDR and CGSB.
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Description Of the Devices 4.
Latex Patient Examination Gloves, LYY, Powder Free
5. The Intended Use of Glove
A medical glove is worn on the hands of healthcare and similar personnel as a barrier against potentially infectious materials and other contamination between healthcare and patient's body, fluid, waste or environment.
- The Quality performance of the glove are shown in the table above 6. meets ASTM D 3578-01 Standard and FDA's requirement
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- The Biocompatibility Test consists of Primary Dermal Irritation Study And the Dermal Sensitization Study. The gloves pass the Biocompatibility Test.
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Public Health Service
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 0 2007
Mr. Abd Hadi Bin Husin Plant Manager MultiSafe Sdn. Bhd. Lot 764, Bidor Industrial Estate, 35500 Bidor, Perak MALAYSIA
Re: K062527
Trade/Device Name: Blue Powder Free Latex Examination Gloves, Non-Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: January 15, 2007 Received: January 26, 2007
Dear Mr. Husin:
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 - Mr. Husin
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.
Ching-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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Applicant :
MULTISAFE SDN. BHD Lot 764, Bidor Industrial Estate, 35500 Bidor, Perak, Malaysia.
Tel No : 605-4348269 Fax No : 605-4348266
510(k) Number (if known) :
KOG2527
Device Name : Blue Powder Free Latex Examination Gloves, Non-Sterile
Indication for Use :
Blue Powder Free Latex Examination Gloves, Non-Sterile is a disposable medical device made from natural rubber latex compound. It is intended to be worn on the hands as a barrier against potentially infectious materials and other contamination.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 -
Elaine S. Mayhall for S. Murphy
062527
§ 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.