(70 days)
A 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.
Vinyl Powder-Free Examination Gloves with coating are formulated using Vinyl and offered powder-free.
The provided text describes a 510(k) summary for "Esteem Stretchy Synthetic with Neu-Thera" examination gloves, not an AI medical device. Therefore, the specific criteria for AI device studies (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable here.
However, I can extract the acceptance criteria and the results of the studies performed for these examination gloves as described in the document.
Acceptance Criteria and Reported Device Performance for Esteem Stretchy Synthetic with Neu-Thera Examination Gloves
| Test | Acceptance Criteria (Implied by "meet or exceed requirements") | Reported Device Performance |
|---|---|---|
| Primary Skin Irritation | No irritation | Gloves show no irritation. |
| Guinea Pig Maximization | No potential for irritation (sensitization) | Gloves do not display any potential for irritation. |
| Tensile Strength | Meet or exceed requirements per ASTM D5250-00e4 | Gloves meet or exceed requirements per ASTM D5250-00e4. |
| Barrier Defects | Meet or exceed requirements per 21 CFR §800.20 and ASTM D5250-00e4 (for pinholes/leaks) | Gloves meet or exceed requirements per 21 CFR§800.20 and ASTM D5250-00e4. |
Regarding the AI-specific questions, based on the provided document, the following are not applicable or cannot be determined:
- Sample sized used for the test set and the data provenance: This information is not relevant for a glove performance test.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for glove performance is based on standardized physical and biological testing methods.
- Adjudication method for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for glove testing is derived from standardized laboratory procedures, chemical analysis, and in-vivo (animal) as well as in-vitro (physical property) testing, typically against established ASTM and CFR standards.
- The sample size for the training set: Not applicable (no AI model).
- How the ground truth for the training set was established: Not applicable (no AI model).
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XIII. SUMMARY OF SAFETY AND EFFECTIVENESS
K052568
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS VINYL POWDER-FREE EXAMINATION GLOVES WITH COATING
Applicant/Sponsor: Cardinal Health 1500 Waukegan Road McGaw Park, IL 60085
Regulatory Affairs Contact: Amy Hoyd Cardinal Health 1500 Waukegan Road, Bldg. WM McGaw Park, IL 60085
Telephone: (847) 578.2325
Fax: (847) 785.2461
Date Summary Prepared: 03 July 2005
Product Trade Name: Esteem Stretchy Synthetic with Neu-Thera
Common Name: Examination Glove
Classification: Patient Examination Glove
Predicate Devices: Vinyl Powder-Free Examination Gloves, Grand Work Plastic Products Co., Ltd.
Description: Vinyl Powder-Free Examination Gloves with coating are formulated using Vinyl and offered powder-free.
Intended Use: These examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
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K052568
payl of 2
K052568 Page 2
Substantial Equivalence: Esteem Stretchy Synthetic with Neu-Thera are substantially equivalent to Grand Work Plastic Products Co., Ltd s Vinyl Powder-Free Examination Gloves in that they provide the following characteristics:
- same intended usc
- same sizes
- both made of Vinyl
- both offered beaded and powder-free
Summary of Testing:
| Test | Result |
|---|---|
| Primary Skin Irritation | Gloves show no irritation. |
| Guinea Pig Maximization | Gloves do not display any potential for irritation. |
| Tensile Strength | Gloves meet or exceed requirements perASTM D5250-00e4. |
| Barrier Defects | Gloves meet or exceed requirements per 21 CFR§800.20and ASTM D5250-00e4. |
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 8 2005
Cardinal Health C/O Mr. Neil Devine Responsible Third Party Official Intertek Testing Services 70 Codman Hill Road Boxborough, Massachusetts 01719
Re: K052568
Trade/Device Name: Esteem Stretchy Synthetic with Neu-Thera Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: November 21, 2005 Received: November 22, 2005
Dear Mr. Devine:
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. Devine
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 your 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,
Chih-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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1500 Waukegan Road McGaw Park, Illinois 60085-6787 847 473 1500 Phone 847 785.2461 Fax
| 510(k) Number: | K052568 |
|---|---|
| Device Name: | Esteem Stretchy Synthetic with Neu-Thera |
| Indications For Use: | A patient examination glove is a disposable deviceintended for medical purposes that is worn on theexaminer's hand or finger to prevent contaminationbetween patient and examiner. |
Prescription Use ( 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
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shiela H. Humphrey MD 11/28/65
non (Sogn-Off) . . 4:00 Sign=On)
Prion of Anestheatulogy, General Hospital, ichsodon Control, Dantal Devices
Number: K 052508
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§ 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.