(239 days)
Intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The fatex examination gloves are used in both the Medical & Dental Communities, to prevent contamination between patient and examiner.
Latex examination gloves - ambidextrous
The provided text is a 510(k) summary for latex examination gloves, not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test and training sets, expert involvement, and ground truth establishment, are not applicable.
However, I can extract information relevant to the regulatory approval process and performance testing of the latex examination gloves.
Here's a summary tailored to the provided text:
Acceptance Criteria and Study for Latex Examination Gloves
This 510(k) pertains to latex examination gloves, not an AI/ML device. The "acceptance criteria" here refer to the standards the gloves must meet to be considered substantially equivalent to a predicate device. The "study" refers to the testing conducted to demonstrate compliance with these standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Predicate Device (Safeskin Satin Plus Latex Examination Gloves) | Kandio Healthcare Corporation (Device under review) |
|---|---|---|
| ASTM D 5712 | Same (Implies compliance) | Completed |
| ASTM 3578-91 | Same (Implies compliance) | Completed |
| Glove Material | Latex | Latex |
| Low Protein | ≤ 50 Micrograms (Claim) | ≤ 50 Micrograms (Claim) |
| Intended Use | Examination | Examination |
| Packaging | 100 Pack dispenser | 100 Pack dispenser |
Explanation of Performance: The device ("Marsin" which is likely the manufacturer mentioned as Marcon Rubber Industrial, Incorporated, whose products include SkinGard TPF, AOSSTEX TPF, SensiFree, Essential TPF, and Amerglo TPF) completed testing according to ASTM D 5712 and ASTM 3578-91, matching the "same" performance characteristics as the predicate device (Safeskin Satin Plus Latex Examination Gloves). This implies the device met the requirements of these standards. The protein content claim of "≤ 50 Micrograms" is also stated as "same" as the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated in the provided text. The ASTM standards (D 5712 and 3578-91) would specify the required sample sizes for their respective tests, but these details are not present in this summary.
- Data Provenance: Not explicitly stated. The tests would likely have been conducted by the manufacturer or a certified lab to demonstrate compliance with ASTM standards.
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 is not applicable as this is not an AI/ML device requiring expert ground truth for image or diagnostic interpretation. The "ground truth" here refers to the physical properties of the gloves as measured by standard laboratory tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 (two readers agree, third resolves) are used for discrepant interpretations in medical imaging or diagnosis. For physical product testing, the results are typically objectively measured against pre-defined specifications.
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, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for latex examination gloves is established through standardized physical and chemical laboratory testing according to ASTM (American Society for Testing and Materials) standards. This includes properties such as:
- Tensile strength
- Elongation
- Freedom from holes
- Dimensions
- Protein content (for low protein claims)
8. The sample size for the training set
Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.
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510(K) SUMMARY (as required by 807.92(c))
MAY 20 1998
Submitter of 510(k):
Regulatory & Marketing Services, Inc. (RMS) 40178 U.S. 19 North Tarpon Springs, FL 34689
813-942-3908 Phone: 813-942-3828 Fax:
Contact Person:
Ed Ransom
Date of Summary:
Trade Name:
Classification Name:
Predicate Device:
Device Description/ Comparison:
August 18, 1997
SkinGard TPF AOSSTEX TPF SensiFree Essential TPF Amerglo TPF
Latex Examination Gloves
Safeskin Satin Plus Latex Examination Gloves
Latex examination gloves - ambidextrous Comparative Chart
| Marsin | Safeskin | |
|---|---|---|
| ASTM D 5712 | completed | same |
| ASTM 3578-91 | Completed | same |
| Glove | Latex | same |
| Low Protein | ≤ 50 Micrograms | same |
| Intended Use | Examination | same |
| Packaging | 100 Pack dispenser | same |
Intended Use:
Intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles facing to the right, and a flowing, ribbon-like element beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 20 1998
Marcon Rubber Industrial, Incorporated ·C/O Mr. Ed Ransom Regulatory & Marketing Services, Incorporated (RMS) 3234 Ella Lane New Port Richey, Florida 34655
Re : K973615 SkinGard TPF/AOSSTEX TPF/SensiFree/Essential Trade Name: TPF/Ameriglo TPF Powder-Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Tess) Regulatory Class: I Product Code: Lyy Dated: April 28, 1998 Received: April 29, 1998
Dear Mr. Ransom:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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), 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 (Premarket Approval), it may . be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ਼ੁ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Ransom
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K973615
Device Name: Powder-Free
A Latex Examination Gloves WITH PROTEIN CONTENT LABELING
CLAIM (50 MICROGRAMS OR LESS)
Proprietary Names:
SkinGard TPF
AOSSTEX TPF
SensiFree
Essential TPF
Amerglo TPF
Indications For Use:
The fatex examination gloves are used in both the Medical & Dental Communities, to prevent contamination between patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devicon
$100
and General Hospital Infect
510(k) Number
(Optional Format 1-2-96)
§ 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.