(16 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Powder Free Nitrile Examination Gloves, Blue
Here's a breakdown of the acceptance criteria and study information for the Powder Free Nitrile Examination Gloves, Blue, based on the provided document:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (per ASTM D 6319-00ae2) | Reported Device Performance (Implied by Certification) |
|---|---|---|
| Dimension | ||
| Length (min.) | Small: 220 mmMedium: 230 mmLarge: 230 mmX-Large: 230 mm | Stated to meet or exceed ASTM D 6319-00ae2 |
| Palm Width | Small: $80\pm10$ mmMedium: $95\pm10$ mmLarge: $110\pm10$ mmX-Large: $120\pm10$ mm | Stated to meet or exceed ASTM D 6319-00ae2 |
| Thickness | Cuff: 0.08 mm (min)Palm: 0.08 mm (min)Finger Tip: 0.08 mm (min) | Stated to meet or exceed ASTM D 6319-00ae2 |
| Physical Properties | ||
| Tensile Strength (Before aging) | 14 Mpa (min) | Stated to meet or exceed ASTM D 6319-00ae2 |
| Ultimate Elongation (Before aging) | 500 % (min.) | Stated to meet or exceed ASTM D 6319-00ae2 |
| Tensile Strength (After aging at 70°C 168 hrs) | 14 Mpa (min) | Stated to meet or exceed ASTM D 6319-00ae2 |
| Ultimate Elongation (After aging at 70°C 168 hrs) | 400 % (min.) | Stated to meet or exceed ASTM D 6319-00ae2 |
| Performance Requirement | ||
| Freedom from holes (AQL) | 2.5 | Meets FDA pinhole requirement (Implied AQL of 2.5 or better) |
| Dimensions (AQL) | 4 | Stated to meet or exceed ASTM D 6319-00ae2 |
| Physical Properties (AQL) | 4 | Stated to meet or exceed ASTM D 6319-00ae2 |
| Powder-free Residue | Exceeds maximum limit (Inspection Level N=5) | Stated to meet or exceed ASTM D 6319-00ae2 |
| Powder Amount | Exceeds recommended maximum limit (Inspection Level N=2) | Stated to meet or exceed ASTM D 6319-00ae2 |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the total sample size for the test set. However, it indicates specific inspection levels (e.g., "Inspection Level I" for freedom from holes, "Inspection Level S-2" for dimensions and physical properties, and specific
Nvalues for powder-free residue and powder amount). These inspection levels and AQLs (Acceptable Quality Levels) are standard in quality control for products like gloves and imply a sampling plan rather than a single fixed "test set" size. - Data Provenance: The data is generated by PT. Shamrock Manufacturing Corp. in Indonesia. The context implies it's retrospective testing conducted on finished products for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of device (medical gloves) does not typically involve "experts" establishing ground truth in the sense of medical diagnosis. The "ground truth" is established by adherence to a recognized international standard, ASTM D 6319-00ae2, which defines objective physical and performance characteristics.
- The individuals conducting the tests would be qualified laboratory technicians or quality control personnel trained in performing the specified ASTM test methods. No specific number or qualifications are provided, but competency in these tests is assumed for ISO/ASTM compliance.
4. Adjudication method for the test set:
- Not applicable in the typical sense for medical device AI/diagnostic studies. Adherence to the ASTM standard would involve objective measurements and pass/fail criteria based on quantitative data rather than expert adjudication.
- For defects like "freedom from holes," the AQL (Acceptable Quality Level) system is an adjudication method, where a certain number of defects within a sample are allowed before the lot is rejected. The AQLs are specified in the table (e.g., 2.5 for holes, 4 for dimensions and physical properties).
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:
- Not applicable. This device is a physical product (medical gloves), not an AI diagnostic tool. Therefore, MRMC studies and human-in-the-loop performance with AI are irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device. The "standalone" performance here refers to the glove's physical and mechanical properties as measured by standard tests, independent of human interaction (other than the testing process itself).
7. The type of ground truth used:
- The ground truth is based on objective measurements and adherence to the performance specifications outlined in the ASTM D 6319-00ae2 standard for Nitrile Examination Gloves. This includes:
- Direct physical measurements (dimensions, thickness).
- Material property tests (tensile strength, ultimate elongation) conducted in a laboratory setting.
- Defined acceptance criteria for defects (e.g., pinholes) based on AQLs.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a "training set." The gloves are manufactured and tested against predefined standards.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device. The "ground truth" for glove characteristics is established by the well-defined, internationally recognized ASTM D 6319-00ae2 standard, which is a consensus standard developed by industry experts and updated over time.
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SEP 1 5 2005 .
PT. Shamrock Manufacturing Corpora
Jalan Pemuda No. 11, Medan-20151, N. Sumatra – Indonesia Ph. (+62-61) 455 8888 Fax. (+62-61) 452 0588 Email. smç@shamrock-id.com ==============================================================================================================================================================================
K052382 "510 (K)" SUMMARY
| (1) Name of applicant | : RUDI SALIM |
|---|---|
| Address | : PT. SHAMROCK Manufacturing Corp.Jl. Pemuda No. 11Medan 20151 - IndonesiaPhone No. : 62-61-4558888 ,- 4558629, - 4520675Fax No. : 62-61-4520588 |
| Contact person in U.S.A | : Emmy Tjoeng |
| Phone No. | : 909-591-8855 |
| Fax No. | : 909-628-6283 |
| (2) Device details | |
| Trade Name | : Powder Free Nitrile Examination Gloves, Blue |
| Classification Name | : Powder Free Nitrile Examination Gloves, Blue |
| (3) Product Code | : 80 LZA |
| (4) Equivalent device legally marketed | : Class I Examination Gloves 80 LZAmeeting ASTM D 6319-00ae2 |
| (5) Intended use | : Powder free Nitrile Examination Glove is a disposabledevice intended for medical purpose that is worn onexaminer's hand to prevent contamination between patientand examiner. |
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| Technological characteristic of the gloves.) | ||||
|---|---|---|---|---|
| a. Dimension | Small | Medium | Large | X-Large |
| Length mm (min.) | 220 | 230 | 230 | 230 |
| Palm Width mm | $80\pm10$ | $95\pm10$ | $110\pm10$ | $120\pm10$ |
| Thickness1. Cuff mm (min) | 0.08 | 0.08 | 0.08 | 0.08 |
| 2. Palm mm(min) | 0.08 | 0.08 | 0.08 | 0.08 |
| 3. Finger Tip mm | 0.08 | 0.08 | 0.08 | 0.08 |
| b. Physical Properties | Before ageing | After ageingat 70°C 168 hrs. | ||
| Tensile Strength | : 14 Mpa (min) | 14 Mpa (min) | ||
| Ultimate Elongation | : 500 % (min.) | 400 % (min.) | ||
| c. Performance Requirement | ||||
| Characteristic | Related Defects | InspectionLevel | AQL | |
| Freedom from holes | Holes | I | 2.5 | |
| Dimensions | Width Length& Thickness | S-2 | 4 | |
| Physical Properties | Before andafter ageing | S-2 | 4 | |
| Powder-free Residue | Exceeds maximum limit | N=5 | N/A | |
| Powder Amount | Exceeds recommendedmaximum limit | N=2 | N/A |
- (6) T
- (7) Performance data is the same as mentioned immediately above.
- (8) Clinical date is not needed for gloves or for most devices cleared by the 510 (K) process.
- (9) Non-clinical data
We certify that our finished powder free nitrile examination gloves meet or exceed the ASTM D 6319-00ae2 Standard. Meets FDA pin hole requirement. Meets labeling claim.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for the Department of Health and Human Services, USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a symbol that appears to be three stylized human profiles facing to the right, with flowing lines above and below them.
Public Health Service
SEP 1 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
PT. Shamrock Manufacturing Corp. C/O Ms. Emmy Tjoeng Shamrock Marketing Company, Inc. 5445 Daniels Street Chino, California 91710
Re: K052382
Trade/Device Name: Powder Free Nitrile Examination Glove, Blue Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: August 19, 2005 Received: September 1, 2005
Dear Ms. Tjoeng:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bectorn of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regars than and the Medical Device Amendments, or to commerce prior to May 26, 1776, the encordance with the provisions of the Federal Food, Drug, devices that have occh reclassince in asses approval of a premarket approval application (PMA). and Cosment Act (Act) market the device, subject to the general controls provisions of the Act. The r ou may, ulercrore, market the Act include requirements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it If your device is classified (500 above) als. Existing major regulations affecting your device can may be subject to such additional controliations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Outs neements concerning your device in the Federal Register.
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Page 2 - Ms. Tjoeng
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase be advised that I browner that your device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of ally Federal statutes and registanents, including, but not limited to: registration and listing (21 Comply with an the For 81 cFR Part 801); good manufacturing practice requirements as set CFR Part 607); adomig (Dr CFR Part 820); and if applicable, the electronic forth in the quant) by sections (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro herems (2005) - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 10 This letter will and will and with gof substantial equivalence of your device to a legally promaticated predicated. The Pro Massification 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 If you desire specific acriveliance at (240) 276-0115. Also, please note the regulation entitled, eonidor the office of Cremarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miorinational 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
Enclosure
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INDICATION FOR USE
| Applicant | : PT. Shamrock Manufacturing Corpora |
|---|---|
| 510(k) Number (if known): | K062382 |
| Device Name | : Powder Free Nitrile Examination Gloves, Blue |
| Indication for use | : |
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to 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)
Shade A. Murphy, KG 9/15/05
ion Sign-Off) (Divis (Division of Anesthosiology, General Hospital, Infection Control. Dental
510(k) Number: `K052382
§ 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.