(60 days)
A patient examination glove is a disposable intended for medical purposes A patient examiner's hand or finger to prevent contamination between patient and examiner
Sterile, powder-free latex examination gloves with polymer coating and protein claim (50 micrograms or less)
Here's an analysis of the provided 510(k) summary, breaking down acceptance criteria and the study information as requested.
The provided document describes Sterile, powder-free latex examination gloves with polymer coating and protein claim (50 micrograms or less). It is a submission for a 510(k) premarket notification, which is a process to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device. This type of submission generally relies on non-clinical performance data and does not typically involve extensive human clinical trials or AI performance evaluations as described for complex AI/ML-based medical devices.
Therefore, many of the requested points related to AI/ML studies (test sets, ground truth establishment, MRMC studies, standalone performance, training sets) are not applicable to this type of device and submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578-2001-ae2 | Meets |
| Physical Properties | ASTM D 3578-2001-ae2 | Meets |
| Freedom from pinholes | ASTM D 3578-2001-ae2 | Meets |
| Powder Free Residue | ASTM D 6124-2001 | $\le$ 2 mg/glove |
| Protein Level | ASTM D 5712-99 | $<$ 50 µg/g |
| Biocompatibility | Primary Skin Irritation in Rabbits | Passes |
| Guinea Pig Sensitization | Passes |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact sample sizes used for each of the non-clinical tests (Dimensions, Physical Properties, Freedom from pinholes, Powder Free Residue, Protein Level, Biocompatibility). These are typically determined by the referenced ASTM standards.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, given it's a submission from Siam Sempermed Corp., Ltd in Thailand, it's likely the testing was conducted in facilities associated with the manufacturer or certified labs in Thailand, or potentially internationally to meet ASTM standards. The tests are inherently prospective as they are performed on manufactured gloves to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device is a physical product (examination glove), and its performance is evaluated against engineering and biological standards using laboratory tests, not human expert interpretation of data or images. "Ground truth" in this context refers to the measured physical or chemical properties of the glove, not expert consensus on an interpretation task.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. As explained above, this submission does not involve interpretation tasks requiring adjudication by multiple experts. Performance is determined by objective measurements against established standards.
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 physical medical device (examination glove), not an AI/ML-based diagnostic or assistive system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device (examination glove), not an AI/ML-based algorithm.
7. The type of ground truth used
- For Dimensions, Physical Properties, Freedom from pinholes, Powder Free Residue, and Protein Level, the ground truth is established by objective measurements and laboratory testing conforming to the specified ASTM standards.
- For Biocompatibility (Primary Skin Irritation in Rabbits and Guinea Pig Sensitization), the ground truth is established by standardized animal testing protocols to assess biological response.
8. The sample size for the training set
- Not Applicable. This device does not involve a "training set" in the context of AI/ML models. It's a manufactured physical product.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply. The performance of the gloves is established through direct testing against defined standards.
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510 (k) Summary As Required by 21 section 807.92 ( c)
-
- Submitter Name: Siam Sempermed Corp., Ltd
JUL 1 9 2005
- 110 Kanjanavanit Road. Pathong Hatyai 2. Address: Songkhla. Thailand 90230
- (+66) 74 291 648 3. Phone:
- (+66) 74 291 650 Fax: 4.
-
- Contract Person: Mrs. Sureerat Choosri (Product Manager)
- Date summary prepared: Mar 31, 2005 6.
- Official Correspondent: Sempermed USA Inc. 7.
- 13900 49th Street North 8. Address: Clearwater, USA , FL 33762
- 727 787 7250 9. Phone:
- 727 787 7558 10. Fax:
- Mr. William E. Harris 11. Contact person:
-
- Device Trade or Proprietary Name: Sterile, powder-free latex examination gloves with polymer coating and protein claim (50 micrograms or less).
-
- Device Common or usual name: Examination glove
-
- Device Classification Name: Glove , Patient Examination , Latex
15. Description of the Device:
ISterile, powder-free latex examination gloves with polymer coating and protein claim (50 micrograms or less)
16. Intended use of the device:
This device is a disposable device intended for medical purpose that is worn on the examiner 's hand to prevent contamination between patient and examiner.
17. Summary of The Technological Characteristics of The devices :
Sterile, powder-free latex examination gloves with polymer coating and protein claim (50 micrograms or less) are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D 3578-2001-ae2 | Meets |
| Physical Properties | ASTM D 3578-2001-ae2 | Meets |
| Freedom from pinholes | ASTM D 3578-2001-ae2 | Meets |
| Powder Free Residue | ASTM D 6124-2001 | $≤$ 2 mg/glove |
| Protein Level | ASTM D 5712-99 | $<$ 50 µg/g |
| Biocompatability | Primary Skin Irritation in RabbitsGuinea Pig Sensitization | PassesPasses |
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18. Substantial Equivalents Based on Assessment of Non-Clinical Performance Data
The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above.
19. Conclusion
It can be concluded that the Sterile, powder-free latex examination gloves with polymer coating and protein claim (50 micrograms or less) will perform according to the glove performance standards referenced in section 17 above and meet ASTM standards, and FDA requirements. Consequently, this device is substantially equivalent to currently marketed device is safe and effective as the predicate device Siam Sempermed Latex Examination Glove , Powder free. Indeed , it is equivalent This is better expressed in the tabulated comparison as below.
Technical comparison of specific elements is attached in the main submission.
| FDA file reference number | 510k number: K970794 |
|---|---|
| Attachments inside notification submission file | REFER TO APPENDIX 1 |
| TECHNOLOGICALCHARACTERISTICS | Comparison resultREFER TO ADDITIONAL TECHNICALCOMPARATIVE TABLE WITHIN 510KSUBMISSION |
| Indications for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Identical |
| Sterility | different |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Identical |
| Anatomical sites | Identical |
| Human factors | Identical |
| Energy used and/or delivered | Identical (Not applicable) |
| Compatibility with environmentand 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 shows the logo for the Department of Health and Human Services (HHS). The logo features the department's name encircling a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement. The caduceus is depicted as a stylized design with a staff and a serpent.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 9 2005
Siam Sempermed Corporation Lịmited. c/o Mr. William E. Harris Sempermed USA, Incorporated 13900 49th Street North Clearwater, Florida 33762
Re: K051329
K031527
Trade/Device Name: Sterile Powder-Free Latex Examination Glove with Polymer Coating and Protein Claim (50 micrograms or less) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient examination glove Regulatory Class: I Product Code: LYY Dated: July 6, 2005 Received: July 11, 2005
Dear Mr. Harris:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(t) pe device is substantially equivalent (for the indications felerenced above and nave acterimes acterimes and one ices marketed in interstate for use stated in the encrosule) to regars actual date of the Medical Device Amendments, or to commerce price to May 20, 1978, as can as a condance with the provisions of the Federal Food, Drug, devices mat have been recuired in assessmon in assessor approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (P and Cosmetic Act (1101) that do novement to the general controls provisions of the Act. The 1 ou may, mercrore, market the act include requirements for annual registration, listing of general controls provisions of the free 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 If your device is classified (soo aboro) and existing major regulations affecting your device can thay be subject to satil additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of Pouchs concerning your device in the Federal Register.
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Page 2 - Mr. Harris
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA s issualled of a succession with other requirements of the Act
that FDA has made a determination that your device complies with other wort that FDA has made a decommances as administered by other Federal agencies. You must of any Federal statutes and regulations daminding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807); labeling (21 CFR Part 800); and If applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections over device as described in your Section 510(k) I his letter will anow you to begin manteling of substantial equivalence of your device to a legally premarket notheation: "The PDA missification 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 advice for your acon 1001) 276-0115. Also, please note the regulation entitled, a Contact the Office of Complanes at (210) = 16 = 21 = 21 = 21 807.97). You may obtain "Misbranding by reference to premanter nouthead in the Act from the Division of Small
other general information on your responsibilities under the Act from the 1990s (23,000 other general International on your responsive and its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free number (800) o Manufacturers, International and Ochoanhows: http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Cluts
Anita Chiu, 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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Indications for Use
510(k) Number (if known): K051329
Device Name: Sterfle Powder-Free Latex Examination Glove with Polymer Coating and Protein Claim (1)
1988 (1994) 1994 (1994) 1994 (1994) (50 micrograms or less)
Indications For Use: A patient examination glove is a disposable intended for medical purposes A patient examiner's hand or finger 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)
Shule A. Murphy, MD 2/18/03
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental De
510(k) Number: A051329
Page 1 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.