(41 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 Latex Examination Gloves
The provided document describes the acceptance criteria and performance data for "Powder Free Latex Examination Gloves" manufactured by PT. Haloni Jane.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria (ASTM D 3578-05ae2 Standard) | Reported Device Performance (PT. Haloni Jane Gloves) |
|---|---|---|
| Dimensions | ||
| Length mm (min.) | 240 (for S, M, L sizes) | 240 (for S, M, L sizes) |
| 240 +/- 5 (for XL size) | 240 +/- 5 (for XL size) | |
| Palm Width mm (min.) | 80 (for Small) | 80 (for Small) |
| 95 (for Medium) | 95 (for Medium) | |
| 105 (for Large) | 105 (for Large) | |
| 110 +/- 10 (for X-Large) | 110 +/- 10 (for X-Large) | |
| Thickness Cuff mm (min.) | 0.1 | 0.1 |
| Palm mm (min.) | 0.1 | 0.1 |
| Finger Tip mm (min.) | 0.1 | 0.1 |
| Physical Properties | ||
| Tensile Strength | 14 Mpa (min) (Before ageing) | 14 Mpa (min) (Before ageing) |
| 14 Mpa (min) (After ageing at 70°C 168 hrs.) | 14 Mpa (min) (After ageing at 70°C 168 hrs.) | |
| Ultimate Elongation | 500 % (min.) (Before ageing) | 500 % (min.) (Before ageing) |
| 400 % (min.) (After ageing at 70°C 168 hrs.) | 400 % (min.) (After ageing at 70°C 168 hrs.) | |
| Pin Hole Requirement | Meets FDA pin hole requirement | Meets FDA pin hole requirement |
| Labeling Claim | Meets labeling claim | Meets labeling claim |
2. Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample size used for the tests.
- The data provenance is prospective, as it describes the results of tests performed on the manufactured gloves. The country of origin of the manufacturer is Indonesia.
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 to this type of device and testing. The acceptance criteria are based on established industry standards (ASTM D 3578-05ae2) rather than expert interpretation of a ground truth in a clinical context.
4. Adjudication method for the test set:
- This information is not applicable. Adjudication methods are typically used in studies where there is subjective interpretation involved, such as reading medical images. For physical property testing of gloves, objective measurements against a standard are performed.
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 information is not applicable. This device is not an AI-assisted diagnostic tool; it is a physical medical device (examination gloves).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. This device is not an algorithm.
7. The type of ground truth used:
- The "ground truth" for the performance of these gloves is defined by objective physical property measurements and adherence to regulatory standards (ASTM D 3578-05ae2 and FDA pin hole requirements). There is no expert consensus, pathology, or outcomes data used as ground truth for this type of product.
8. The sample size for the training set:
- This information is not applicable. As this is not a machine learning or AI device, there is no concept of a "training set."
9. How the ground truth for the training set was established:
- This information is not applicable.
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PT. Haloni Jane
10,2
Jalan Raya Serang Km. 13,8 Cikupa – Tangerang Indonesia Ph. (+62-21) 596 2435 Fax (+62-21) 596 2436 Email halloni@telkom.net
"510 (K)" SUMMARY
| (1) Name of applicantAddress | : ANDY TANAKA: PT. Haloni JaneJl. Raya Serang Km. 13.8Cikupa - TangerangIndonesiaPhone No. : 62-61-5962435Fax No. : 62-61-5962436 | NOV - 9 2006 |
|---|---|---|
| Contact person in U.S.A | : Emmy TjoengPhone No. : 909-591-8855Fax No. : 909-628-6283 | |
| (2) Device detailsTrade NameClassification Name | : Powder free Latex Examination Gloves: Powder free Latex Examination Gloves | |
| (3) Product Code | : 80 LYY | |
| (4) Equivalent device legallymarketed | : Class I Examination Gloves 80 LYY, Powder Freemeeting ASTM D 3578-05ae2 | |
| (5) Intended use | : Powder free Latex Examination gloves is a disposable deviceintended for medical purpose that is worn on examiner's hand toprevent contamination between patient and examiner. |
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PT. Haloni Jane
KOG2955
222
Jalan Raya Serang Km. 13,8 Cikupa – Tangerang Indonesia Ph. (+62-21) 596 2435 Fax (+62-21) 596 2436 Email haloni@telkom.net
| (6) Technological characteristic of the gloves. | ||||
|---|---|---|---|---|
| a. DimensionsSizes | Small | Medium | Large | X-Large |
| Length mm (min.) | 240 | 240 | 240 | 240 $\pm$ 5 |
| Palm Width mm | 80 | 95 | 105 | 110 $\pm$ 10 |
| Thickness | ||||
| 1. Cuff mm (min) | 0.1 | 0.1 | 0.1 | 0.1 |
| 2. Palm mm(min) | 0.1 | 0.1 | 0.1 | 0.1 |
| 3. Finger Tip mm | 0.1 | 0.1 | 0.1 | 0.1 |
| 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.) |
(7) Performance data is the same as mentioned immediately above.
(8) Clinical data is not needed for gloves or for most devices cleared by the 510 (K) process.
(9) Non-clinical data
We certify that our final finished powder free latex examination gloves meet or exceed the ASTM D 3578-05ae2 Standard. Meets FDA pin hole requirement.
Meets labeling claim.
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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV ~ 9 2006
PT. Haloni Jane C/O Ms. Emmy Tjoeng Marketing Director Shamrock Marketing Company, Incorporated 5445 Daniels Street Chino, California 91710
Re: K062955
Trade/Device Name: Powder Free Latex Examination Gloves, Small, Medium, Large Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: October 26, 2006 Received: October 31, 2006
Dear Ms. Tjoeng:
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 - Ms. Tjoeng
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,
Auy Sullom bor
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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ANNEXURE II
INDICATION FOR USE
| Applicant | : PT. Haloni Jane |
|---|---|
| 510(k) Number (if known) | : K062955 |
| Device Name | : Powder Free Latex Examination Gloves |
| 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)
Over-The-Counter Use AND/OR x (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)
Shule A. Mighley 12
f Anesthesiology, General Hospital,
ion Control, Dental Devices
Number K062953
§ 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.