(186 days)
A Powdered Latex Examination Glove Non Sterile is a disposable device made of natural rubber latex that bears powder to facilitate donning and is intended to be worn on the hand of finger(s) for a medical purpose to provide a barrier againts potentially insfectious material and other contaminations.
The Powdered Latex Examination Gloves, Non Sterile (Contains 200 micrograms or less of Total Water Extractable Protein per dm4) meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.
The provided document outlines the acceptance criteria and performance of a device, but it is not a study in the typical sense of a clinical trial or comparative effectiveness research. Instead, it is a 510(k) Premarket Notification Summary for a medical device (Powdered Latex Examination Gloves, Non Sterile), which aims to demonstrate substantial equivalence to a predicate device.
Here's the breakdown of the acceptance criteria and reported device performance based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM D 3578-01ae2 | Meets |
| Physical Properties | ASTM D 3578-01ae2 | Meets |
| Freedom from Pinholes | ASTM D 3578-01ae2 FDA 21 CFR 800.20 (1000 ml Water Leak Test) | Meets |
| Powder Residue | ASTM D 3578-01ae2, ASTM D 6124-01 | < 10 mg/dm² |
| Water Soluble Protein Content | ASTM D 3578-01ae2, ASTM D 5712-99 | < 200 µg/dm² |
| Biocompatibility (Primary Skin Irritation) | Primary Skin Irritation in Rabbits (Method not specified in detail, but standard for biocompatibility) | Passes |
| Biocompatibility (Dermal Sensitization) | Dermal Sensitization (Method not specified in detail, but standard for biocompatibility) | Passes |
2. Sample Size Used for the Test Set and Data Provenance
The document states:
- "The samples are from the final product." (for non-clinical performance data)
- "The sample items used during the Primary Skin Irritation Test and the Dermal Sensitization Test is from the final product." (for clinical performance data, which in this context refers to biocompatibility testing).
Sample Size: The exact sample size used for each specific test (e.g., how many gloves were tested for pinholes, how many rabbits for biocompatibility) is not specified in the provided summary.
Data Provenance: The device manufacturer is PT. MAHAKARYA INTI BUANA, located in SUMUT – INDONESIA. This suggests the testing was either conducted in Indonesia or by a laboratory contracted by the Indonesian manufacturer. The data appears to be prospective in the sense that the tests were performed specifically for this 510(k) submission on samples of the final product.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable/Not described. This document is for a physical medical device (gloves), not an AI diagnostic or image analysis system. The "ground truth" here is objective physical and chemical measurements (e.g., dimensions, protein content, water leak) and results of standardized biological tests (e.g., skin irritation in rabbits), not expert interpretation of medical images or patient outcomes. Therefore, there's no mention of experts establishing ground truth in the way it would be for an AI study.
4. Adjudication Method for the Test Set
Not applicable. As mentioned above, this is about objective measurements against predefined standards, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. No MRMC study was performed or is relevant for this type of device (examination gloves). This type of study focuses on improving human reader performance with AI assistance, which is not the purpose of this submission.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This device is a passive physical barrier, not an algorithm or software. Therefore, the concept of standalone algorithm performance does not apply.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is based on:
- Objective Measurements: Directly measurable physical and chemical properties of the gloves (e.g., dimension, weight of powder, protein concentration).
- Standardized Test Results: Outcomes of well-established test methods described by ASTM standards and FDA regulations (e.g., water leak test for pinholes, specific tests for biocompatibility like Primary Skin Irritation in Rabbits and Dermal Sensitization).
8. Sample Size for the Training Set
Not applicable. This submission is for a physical medical device and does not involve AI or machine learning models that require a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, this question is not relevant.
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Image /page/0/Picture/0 description: The image shows a stylized, black and white graphic of the letters 'MB' in a gothic or medieval-style font. The letters are bold and blocky, with sharp angles and thick strokes, giving them a somewhat imposing appearance. The overall design has a vintage or old-fashioned feel due to the font choice and the slightly rough or textured quality of the image.
1.0
PT. MAHAKARYA INTI BUANA
JUN - 2 2006
Jalan Sei Belumai Desa Dalu 10 A Dusun 1 Tanjung Morawa - 20362 SUMUT - INDONESIA
Tel +62-61-7944880 +62-61-7944882 Fax
| 510 (K) SUMMARY | K063305 | |
|---|---|---|
| Submitter: | ||
| Name | PT. MAHAKARYA INTI BUANA | |
| Address | Jl. Sei Belumai, Desa Dalu 10 A Dusun I No. 18 Tanjung Morawa - 20362 SUMUT – INDONESIA |
| Phone No. | +62-61-7944880 |
|---|---|
| Fax No. | +62-61-7944882 |
| Date of Summary Prepared |
2.0 Contact Person:
| Name | : | Mr. V. Nadarajan |
|---|---|---|
| Phone | : | +62-61-7944880 |
| Fax No. | : | +62-61-7944882 |
3.0 Name or the device:
| Trade Name | 1) Senstouch and2) Multiple or Customers' Trade Name |
|---|---|
| Device Name | Powdered Latex Examination Gloves, 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, LYY, Powdered, 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 Powdered Latex Examination Gloves, Non Sterile (Contains 200 micrograms or less of Total Water Extractable Protein per dm4) 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 Powdered Latex Examination Glove, Powdered, Non Sterile is a disposable device intended for medical purposes that is worn on the examiner'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 a stylized, black and white graphic of the letters "MB" in a gothic or old English font. The letters are bold and have a textured appearance, giving them a slightly rough or aged look. The overall design is simple yet striking, with the letters being the primary focus.
11053305
Jalan Sei Belumai Desa Dalu 10 A Dusun 1 Tanjung Morawa - 20362 SUMUT - INDONESIA
Tel +62-61-7944880 +62-61-7944882 Fax
Summary of The Technological Characteristics of The Device 7.0
The Powdered Latex Examination Gloves, Powdered, Non Sterile (Contains 200 micrograms or less of Total Water Extractable Protein per dm2) 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 Residue | D 3578 -01 ae2D6124 - 01 | < 10 mg/dm² |
| Water Soluble ProteinContent | D 3578 -01 ae2D 5712 - 99 | < 200 µg/dm² |
| Biocompatibility | Primary Skin Irritation inRabbits | Passes |
| Dermal Sensitization | Passes |
- 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. The samples are from the final product.
- Substantial Equivalent Based on Assessment of Clinical Performance Data 9.0 The sample items used during the Primary Skin Irritation Test and the Dermal Sensitization Test is from the final product.
10.0 Conclusion
It can be concluded that The Powdered Latex Examination Gloves, Non Sterile (Contains 200 micrograms or less of Total Water Extractable Protein per dm') 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 U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN =2 2006
Mr. V. Nadarajan Manager, QA/RA Jalan Sei Belumai Desa Dalu 10 A Dusun 1 No. 18 Tanjung Morawa-20362 SUMUT-INDONESIA
Re: K053305
Trade/Device Name: Senstouch Powdered Latex Examination Glove, Non Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: May 10, 2006 Received: May 15, 2006
Dear Mr. Nadarajan:
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. Nadarájan
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device 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 vours.
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
510(k) Number (if known): 《OS 3305
Device Name: . .
POWDERED LATEX EXAMINATION GLOVE, NON STERILE
Indications For Use:
A Powdered Latex Examination Glove Non Sterile is a disposable device made of natural rubber latex that bears powder to facilitate donning and is intended to be worn on the hand of finger(s) for a medical purpose to provide a barrier againts potentially insfectious material and other contaminations.
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)
Clues
Page 1 of 1
i & Anesthesiology, General Hospital,
ion Control, Dental Devices
§ 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.