(39 days)
Olymer Examination Glove , Powder Free Non Sterile is a disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purpose that is worn on the examiner's hand or finger or prevent contamination between patient and examiner.
The Polymer Examination Gloves, Powder Free, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
The document describes the PT. MAHAKARYA INTI BUANA Polymer Examination Gloves, Powder Free, Non Sterile. The provided information focuses on non-clinical performance data and does not include details on clinical studies or AI-driven aspects.
1. Table of Acceptance Criteria and Reported Device Performance
| CHARACTERISTICS | STANDARDS | ACCEPTANCE CRITERIA (implied by "Meets" or specific values) | REPORTED DEVICE PERFORMANCE |
|---|---|---|---|
| Dimension | D 3578 -01 ae² | Meets D 3578 -01 ae² | Meets |
| Physical Properties | D 3578 -01 ae² | Meets D 3578 -01 ae² | Meets |
| Freedom from Pinholes | D 3578 -01 ae²FDA 21 CFR 800.20 | Meets D 3578 -01 ae² and FDA 21 CFR 800.20 | Meets |
| Powder Free Residue | D 3578 -01 ae²D6124 - 01 | < 2 mg/glove | < 2 mg/glove |
| Water Soluble Protein Content | D 3578 -01 ae²D 5712 - 99 | < 50 µg/g | < 50 µg/g |
| Biocompatibility (Skin Irritation) | Primary Skin Irritation in Rabbits | Passes (No Primary Skin Irritation) | Passes |
| Biocompatibility (Sensitization) | Dermal Sensitization | Passes (No contact sensitizer) | Passes |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for testing each characteristic. It also does not explicitly state the country of origin of the data for these tests, nor whether they were retrospective or prospective. Given the nature of a 510(k) submission for examination gloves, these would typically be conducted by the manufacturer in a controlled laboratory setting (prospective testing) following the specified ASTM and FDA standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The measurements and assessments for these physical and chemical characteristics of gloves are determined by standardized test methods (e.g., ASTM standards) and laboratory procedures, not by expert interpretation or ground truth established by medical experts in the way that imaging or diagnostic AI would require.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods are typically relevant for subjective assessments or when there's disagreement among human readers/experts, which is not the case for the objective physical, chemical, and biological tests described.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This product is a physical device (examination gloves), not an AI-driven diagnostic or assistive tool. Therefore, studies comparing human reader performance with and without AI assistance are not relevant and were not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical product (examination gloves), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for these tests is defined by the objective criteria and methodologies outlined in the referenced ASTM and FDA standards (e.g., specific measurement techniques for dimensions, visual inspection criteria for pinholes, chemical assays for protein content, and animal testing protocols for biocompatibility). There is no "expert consensus" or "pathology" involved in establishing the ground truth for glove performance tests in the context of this submission.
8. The sample size for the training set
This is not applicable. The product is a physical device, and the testing described is not related to machine learning or AI, which would require a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for a machine learning model.
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Image /page/0/Picture/0 description: The image shows a stylized logo with the letters "MB" in a bold, gothic-style font. The letters are black and appear to be hand-drawn or digitally rendered with a rough, textured edge. The overall design has a vintage or medieval feel due to the font choice and the solid black fill.
PT. MAHAKARYA INTI BUANA
Jalan Sei Belumai Desa Dalu 10 A Dusun 1 Tanjung Morawa -- 20362 SUMUT - INDONESIA
Tiel +62-61-7944880 +62-61-7944882 liax
510 (K) SUMMARY
| 1.0 | Submitter: | ||
|---|---|---|---|
| Name | : | PT MAHAKARYA INTI BUANA | |
| Address | : | Jl. Sei Belumai, Desa Dalu 10 A Dusun I No. 18Tanjung Morawa - 20362SUMUT – INDONESIA | |
| Phone No. | : | +62-61-7944880 | |
| Fax No. | : | +62-61-7944882 | |
| Date of Summary Prepared | : |
2.0 Contact Person:
| Name | : | Mr. Sasitharan Nair |
|---|---|---|
| Phone | : | +62-61-7944880 |
| Fax No. | : | +62-61-7944882 |
SEP 3 0 2005
3.0 Name or the device:
| Trade Name | 1) Senstouch and2) Multiple or Customers' Trade Name |
|---|---|
| Device Name | Polymer Latex Examination Gloves, Powder Free, Non Sterile |
| Common Name | Examination Gloves |
| Classification Name | Patient Examination Gloves (Class I) |
4.0 Identification of The Legally Marketed Device:
Class I Examination gloves, 80 LYY, Powder Free, that meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.
5.0 Description of The Device
The Polymer Examination Gloves, Powder Free, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.
6.0 Intended Use of The Device
The Polymer Examination Glove, Powder Free, Non Sterile is a disposable device intended for medical purposes that is worn on the examincr's to prevent contamination between patient and examiner.
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PT. MAHAKARYA INTI BUANA
Image /page/1/Picture/1 description: The image shows an address written in a block of text. The address is "Jalan Sei Belumai Desa Dalu 10 A Dusun 1 Tanjung Morawa - 20362 SUMUT -- INDONESIA". The address appears to be located in Indonesia.
Ticl 162-61-7944880 +62-61-7944882 l'ax
Summary of The Technological Characteristics of The Device 7.0
The Polymer Examination Gloves, Powder Free, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) are summarized with the following technological characteristics compared to ASTM equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICEPERFORMANCE |
|---|---|---|
| Dimension | D 3578 -01 ae² | Meets |
| Physical Properties | D 3578 -01 ae² | Meets |
| Freedom from Pinholes | D 3578 -01 ae²FDA 21 CFR 800.20 | Meets |
| Powder Free Residue | D 3578 -01 ae²D6124 - 01 | < 2 mg/glove |
| Water Soluble ProteinContent | D 3578 -01 ae²D 5712 - 99 | < 50 µg/g |
| Biocompatibility | Primary Skin Irritation inRabbits | Passes(No Primary Skin Irritation) |
| Biocompatibility | Dermal Sensitization | Passes(No contact sensitizer) |
- 8.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data The performance test data of the non-clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above.
- 9.0 Substantial Equivalent Based on Assessment of Clinical Performance Data Clinical data is not needed for gloves or for most devices cleared by the 510 (k) processes.
10.0 Conclusion
It can be concluded that The Polymer Examination Gloves, Powder Free, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) will perform according to the gloves performance standards referenced in Section (7) above and meet ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features the department's symbol, which consists of a stylized human figure with three arms or lines extending from the head, along with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
SEP 3 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Sasitharan Nair TOM Managaer PT. Mahakarya Inti Buana J1. Sei Belumani, Desa Dalu 10 A Dusun No. 18, Tanjung Morawa, Sumut, INDONESIA 20362
Re: K052273
Trade/Device Name: Polymer Coated Latex Examination Glove, Powder Free, Non Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: September 22, 2005 Received: September 26, 2005
Dear Mr. Nair:
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. Nair
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 vour 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,
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
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Indications for Use
510(k) Number (if known):
Device Name: POLYMER EXAMINATION GLOVE, POWDER FREE, NON STERILE Indications For Use: "Olymer Examination Glove , Powder Free Non Sterile is a disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purpose that is worn on the examiner's hand or finger or prevent contamination between patient and examiner.
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)
Shail H. Murchison, MD a bules-
(Division Sign-Off) person Oigh-Old)
Division of Anesthesiology, General Hospital, Infection Control, Dental Dental Devices Page 1 of 1 510(k) Number
ge 1 of 1
§ 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.