(76 days)
THIS DEVICE IS A DISPASABLE DEVICE INTENDED for MEDICAL PURPOSES THAT IS WERN ON THE EXAMINER'S Official T AND HAND TO PREVENT CONTAMINATION SETWEEN EXAMINER
SATARI® latex patient examination glove, is a powder glove single side polymer coated, non sterile, 200 ug or less of total water extractable protein per gram, 10 mg/dm- or less of residual powder
The provided text is a 510(k) summary for the SATARI® latex patient examination glove. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria through performance evaluation.
Therefore, many of the requested sections about study design, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness simply cannot be answered from the provided document. The document does not describe such a study.
However, I can extract the acceptance criteria that are implied through the device description and the "identical" or "similar" comparisons.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are inferred from the description of the device and the comparison to the predicate device. Since the device claims substantial equivalence, the "acceptance criteria" are essentially matching the characteristics of the predicate device and meeting regulatory standards for examination gloves.
| Acceptance Criterion | Reported Device Performance (as stated in document) |
|---|---|
| Total water extractable protein | "200 µg or less of total water extractable protein per gram" |
| Residual powder | "10 mg/dm² or less of residual powder" |
| Intended Use | "Identical" to predicate: "A disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." |
| Target Population | "Identical" to predicate |
| Design | "Similar" to predicate |
| Materials | "Identical" to predicate |
| Performance | "Identical" to predicate (Implies meeting the same physical performance standards like tensile strength, puncture resistance, etc., but specific values are not provided in this summary) |
| Sterility | "Identical" to predicate (Non-sterile) |
| Biocompatibility | "Identical" to predicate |
| Mechanical Safety | "Identical" to predicate |
| Chemical Safety | "Identical" to predicate |
| Anatomical Sites | "Identical" to predicate |
| Human Factors | "Identical" to predicate |
| Where Used | "Identical" to predicate |
| Standards Met | "Identical" to predicate (Implies meeting relevant ASTM or ISO standards for examination gloves, but specific standards are not listed in the provided text). |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. The document does not detail a specific performance study with a test set. It relies on a comparison to a predicate device and states "Technical comparison of specific elements is attached in the main submission."
- Data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth establishment by experts for a test set is described.
4. Adjudication method for the test set:
- Not applicable. No adjudication method is described as there is no specific test set study detailed.
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 is a medical glove, not an AI diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical glove, not an algorithm.
7. The type of ground truth used:
- Not applicable in the sense of a diagnostic or imaging study. The "ground truth" for this device's performance would be adherence to established material specifications, manufacturing standards, and regulatory requirements for patient examination gloves. The document implies compliance through comparison to its predicate device and adherence to listed protein and powder limits.
8. The sample size for the training set:
- Not applicable. This document does not describe a training set as it's not a machine learning or AI device.
9. How the ground truth for the training set was established:
- Not applicable. This document does not describe a training set.
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K01412
510(k) Summary As Required by 21 section 807.92 ( c )
FEB 2 8 2002
1-Submitter Name: Siam Sempermed Corp., Ltd
110 Moo 8 Kanjanavanit Road. Pathong Hatyai 2-Address: Songkhla. Thailand 90230
| 3-Phone: | (++66) 074 291 648 |
|---|---|
| 4-Fax: | (++66) 074 291 650 |
| 5-Contact Person: | Dr Poonsuk Cherdkiatgumchai (Chief Quality Officer) |
| 6-Date summary prepared: | December 7th, 2001 |
| 7- Official Correspondent: | Mansour Consulting |
| 8- Address: | 1308 Morningside Park DrAlpharetta, GA 30022 USA |
| 9- Phone: | (678) 908-8180 |
| 10- Fax: | (425) 795-9341 |
| 11- Contact person: | Jay Mansour, president |
| 12-Device Trade or Proprietary Name: | SATARI® latex patient |
examination powdered glove single side polymer coated, non sterile, 200 µg or less of total water extractable protein per gram, 10 mg/dm2 or less of residual powder
13-Device Common or usual name: Examination glove
14-Device Classification Name: Glove, Patient Examination, Latex
15-Substantial Equivalency is claimed against the following device:
Siam Sempermed Latex Patient Examination Glove Polymer powder free, 510k #K981096 (refer to Appendix 2 for FDA website printout. This notification for the SATARI® latex examination glove is of the ABBREVIATED type as per the declaration of conformity on page 4 of this summary
11-Description of the Device:
SATARI® latex patient examination glove, is a powder glove single side polymer coated, non sterile, 200 ug or less of total water extractable protein per gram, 10 mg/dm- or less of residual powder
12-Intended use of the device: (Indications for use typed on a separate FDA form)
This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner
13-Safety and effectiveness of the device:
This device is safe and effective as the predicate device Siam Sempermed Latex Patient Examination Glove polymer, powder-free. Indeed, it is equivalent.
This is better expressed in the tabulated comparison (Paragraph 14 below)
14-Summary comparing technological characteristics with other predicate device:
PAGE 3.1
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General comparison result between SATARI® latex examination glove and the predicate device (Siam Sempermed Latex Patient Examination Glove polymer, powder-free) is tabulated below.
014112
Technical comparison of specific elements is attached in the main submission
| FDA file reference number | 510k 970794 |
|---|---|
| Attachments inside notificationsubmission file | REFER TO APPENDIX 2 |
| TECHNOLOGICALCHARACTERISTICS | Comparison resultREFER TO ADDITIONAL TECHNICALCOMPARATIVE TABLE WITHIN 510K SUBMISSION |
| Indications for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Identical |
| Performance | Identical |
| Sterility | Identical |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Identical |
| Anatomical sites | Identical |
| Human factors | Identical |
| Energy used and/or delivered | Identical (not applicable) |
| Compatibility withenvironment and other devices | Identical |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Identical (not applicable) |
| Thermal safety | Identical (not applicable) |
| Radiation safety | Identical (not applicable) |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird with three wing-like shapes and a flowing tail.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 8 2002
Siam Sempermed Corporation Limited C/O Mr. Jay Mansour Mansour Consulting 1308 Morningside Park Drive Alpharetta, Georgia 30022
Re: K014112
Trade/Device Name: Satari Powdered Latex Examination Gloves with Protein Content Labeling Claim ( 200 Micrograms or Less) Polymer Coated White, Pink and Blue Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: December 10, 2001 Received: December 14, 2001
Dear Mr. Mansour:
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. Mansour
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 a!l 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Timothy Ulatowski
Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known): K014112
SATART® LATEX PATIENT EXAMINATION POWDERED GLOVE,
Device Name: SINGLE SIDE POLYMER COATED, NON STERILE 200μg OR LESS
OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM, 10mg/dm² or LESS
Indications For Use: (white, Pink, and Blue)
THIS DEVICE IS A DISPASABLE DEVICE INTENDED for MEDICAL PURPOSES THAT IS WERN ON THE EXAMINER'S Official T AND HAND TO PREVENT CONTAMINATION SETWEEN EXAMINER
PLEASE DO NOT WRITE BELOW THIS LINE - CONTROLLED DOCUMENT
Commission of CSRA, Office of Dispute Resolution (ODR)
Qhin S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices ! 10(k) Number
Prescription Use (Per 21 CFR 801. 109)
OR
Over-The-Counter Use X
(Optional Format 1-2-85)
Page 4 of
§ 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.