(76 days)
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
SATARI® latex patient examination glove, is a powder glove single side polymer coated, non sterile, 50 ug or less of total water extractable protein per gram, 10 mg/dm2 or less of residual powder
The provided 510(k) summary (KO14110) describes a medical device, the SATARI® latex patient examination powdered glove. It claims substantial equivalence to a predicate device, Siam Sempermed Latex Patient Examination Glove Polymer powder-free (K981096). This submission is for an ABBREVIATED 510(k) type, which typically relies on established performance standards and a declaration of conformity, implying the device meets pre-defined criteria rather than requiring extensive new clinical studies.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly present a table of numerical acceptance criteria with reported performance values for properties like tensile strength, elongation, or protein content. Instead, it claims "Identical" or "Similar" for various technological characteristics when compared to the predicate device. This is typical for an Abreviated 510(k) where conformity to recognized standards often replaces detailed performance tables.
However, specific claims about the device's characteristics that would need to meet certain standards (and thus act as acceptance criteria) are mentioned:
| Acceptance Criteria (Derived from Device Description/Claims) | Reported Device Performance (Implied by "Identical"/ "Similar" to K981096 and descriptions) |
|---|---|
| Total water extractable protein per gram: ≤ 50 µg | ≤ 50 µg (Stated in device name and description, and implied by substantial equivalence to a predicate that would meet similar protein limits for examination gloves) |
| Residual powder: ≤ 10 mg/dm² | ≤ 10 mg/dm² (Stated in device name and description, and implied by substantial equivalence to a predicate that would meet similar powder limits for examination gloves) |
| Indications for Use: Disposable, for medical purposes, worn on examiner's hand to prevent contamination between patient and examiner | Identical to predicate device (Stated in comparison table) |
| Target population: (Not explicitly defined, but implied for general medical examination use) | Identical to predicate device (Stated in comparison table) |
| Design: (Physical attributes of the glove) | Similar to predicate device (Stated in comparison table) |
| Materials: (Type of latex, polymer coating) | Identical to predicate device (Stated in comparison table) |
| Performance: (e.g., Barrier integrity, physical properties like tensile strength, elongation) | Identical to predicate device (Stated in comparison table, likely referring to compliance with ASTM D3578) |
| Sterility: Non-sterile | Identical (Non-sterile) to predicate device (Stated in comparison table) |
| Biocompatibility: (No adverse reactions) | Identical to predicate device (Stated in comparison table) |
| Mechanical safety: (e.g., tear resistance) | Identical to predicate device (Stated in comparison table) |
| Chemical safety: (e.g., absence of harmful leachables) | Identical to predicate device (Stated in comparison table) |
| Anatomical sites: Hand | Identical to predicate device (Stated in comparison table) |
| Human factors: (Ease of donning/doffing, fit, comfort) | Identical to predicate device (Stated in comparison table) |
| Standards met: (e.g., relevant ASTM standards for medical gloves) | Identical to predicate device (Stated in comparison table, implying compliance with recognized standards) |
The "study that proves the device meets the acceptance criteria" in this context is the declaration of conformity to established standards and the demonstration of substantial equivalence to the predicate device. For an abbreviated 510(k), the detailed test results are typically summarized or declared as meeting specified standards, rather than presenting a full, independent study write-up. The submission references "ADDITIONAL TECHNICAL COMPARATIVE TABLE WITHIN 510K SUBMISSION" which would contain details if this were a traditional submission.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The provided text does not specify the sample size used for any testing or the data provenance. For an abbreviated 510(k) for a well-established device like examination gloves, testing would typically involve standard methods (e.g., ASTM D3578 for rubber examination gloves) on representative batches of the manufactured product. The facility location (Thailand) suggests the tests would be performed on gloves manufactured there, but direct data provenance is not stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable and not provided. This device is a physical medical glove, not a diagnostic or AI-driven device requiring expert interpretation for "ground truth" establishment in a diagnostic sense. Performance is assessed through objective physical and chemical tests (e.g., tensile strength, protein content).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. Adjudication methods are typically used in clinical studies for diagnostic accuracy, where multiple experts evaluate cases to reach a consensus on "ground truth." For physical device testing, objective measurement methods are used.
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 and not provided. This device is not an AI-assisted diagnostic tool, so an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided. This device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance would be the objective measurements obtained from standardized physical, chemical, and biological tests (e.g., ASTM standards for mechanical properties like tensile strength and elongation, validated laboratory methods for protein content and barrier integrity). Pathology or outcomes data are not directly relevant for evaluating the intrinsic performance of an examination glove.
8. The sample size for the training set:
This information is not applicable and not provided. This device is not an machine learning model requiring a training set.
9. How the ground truth for the training set was established:
This information is not applicable and not provided. As above, this device is not an machine learning model.
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KO14110 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
(++66) 074 291 648 3-Phone: 3-Phone:
4-Fax:
5-Contact Person: Dr Poonsuk Cherdkiatgumchai (Chief Quality Officer)
6-Date summary prepared: December 7th, 2001
7- Official Correspondent: Mansour Consulting
(++66) 074 291 650
8- Address:
1308 Morningside Park Dr Alpharetta. GA 30022 USA
- (678) 908-8180 9- Phone:
10- Fax:
11- Contact person: Jay Mansour, president
12-Device Trade or Proprietary Name: SATARI® latex patient examination powdered glove single side polymer coated, non sterile, 50 µg or less of total water extractable protein per gram, 10 mg/dm2 or less of residual powder
(425) 795-9341
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, 50 ug or less of total water extractable protein per gram, 10 mg/dm2 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:
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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.
Technical comparison of specific elements is attached in the main submission
| FDA file reference number | 510k 970794 |
|---|---|
| Attachments inside notification submission file | REFER TO APPENDIX 2 |
| TECHNOLOGICAL CHARACTERISTICS | 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 with environment 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/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three wavy lines, which are likely meant to represent a symbol or logo for the department.
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: K014110
Trade/Device Name: Satari Powdered Latex Examination Gloves with Protein Content Labeling Claim ( 50 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 moun that I Dr man mass statutes and regulations administered by other Federal agencies. or the receingly 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 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 the receinal be sense 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,
A. Ulatowski Timt Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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P
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| 510(k) Number (if known): | K014110 |
|---|---|
| Device Name: | SATARI® LATEX PATIENT EXAMINATION POWDERED GLOVE,SINGLE SIDE POLYMER COATED, NON STERILE, 50mg OR LESS of |
| Indications For Use: | TOTAL WATER EXTRACTABLE PROTEIN PER GRAM, 10mg/dm² OR LESSOF RESIDUAL POWDER (White, Pink AND BLUE) |
THIS DEVICE IS A DISPOSABLE DEVICE INTENDED EXAMINER'S PURPOSES THAT IS WORN ON THE for MEDICAL PATIENT AND PREVENT CONTAMINATION BETWEEN ಗೆ HAND EXAMINER
(PLEASE DO
Concurrence of CDRH, Office of Device Evaluation (ODE)
Olin S. Lin
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number: K014110
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use X
(Optional Format 1-2-96)
AGC C3
§ 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.