(51 days)
Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol are non-sterile disposable devices intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
This document describes the acceptance criteria and performance of the Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol.
Here's an analysis of the provided information:
Acceptance Criteria and Device Performance
The device, "Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol," is a medical examination glove. Its acceptance criteria and reported performance are based on its compliance with established ASTM standards and additional biocompatibility tests.
Acceptance Criteria and Reported Device Performance Table:
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3578-01a€2 | Meets ASTM D 3578-01a€2 |
| Physical Properties | Meets ASTM D 3578-01a€2 | Meets ASTM D 3578-01a€2 |
| Freedom from Holes | Meets ASTM D 3578-01a€2 | Meets ASTM D 3578-01a€2 |
| Meets ASTM D 5151-99 | Meets ASTM D 5151-99 | |
| Powder-Free | Meets ASTM D 3578-01a€2 | Meets ASTM D 3578-01a€2 |
| Not more than 2 mg residue by mass per glove | Not more than 2 mg residue by mass per glove (implied by meeting ASTM standard) | |
| Biocompatibility | Primary Skin Irritation in Rabbits: Pass requirement | Passes |
| Guinea Pig Sensitization: Pass requirement | Passes |
Study Details for Device Performance
Based on the provided document, the device's performance is demonstrated through adherence to recognized industry standards, primarily ASTM D 3578-01a€2 and ASTM D 5151-99, along with specific biocompatibility tests.
1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify the exact sample sizes used for testing each characteristic (e.g., number of gloves tested for dimensions, holes, etc.).
- The data provenance is not explicitly stated in terms of country of origin, nor is it categorized as retrospective or prospective. However, the tests are performed to demonstrate compliance with ASTM standards, which are generally established protocols.
2. 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 to this type of device and study. The "ground truth" for glove performance is determined by established engineering specifications and chemical testing protocols outlined in the ASTM standards and biocompatibility tests, not by expert consensus on interpretation.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Performance is determined by objective measurements against quantitative or qualitative pass/fail criteria defined by the ASTM standards and biocompatibility tests.
4. 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 not an AI/imaging device.
5. 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 algorithm. The performance is inherent to the product's physical and chemical properties.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device is based on established engineering and material science specifications as defined in the ASTM standards (D 3578-01a€2 for general examination glove requirements, D 5151-99 for freedom from holes) and standardized biological testing protocols for biocompatibility (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization). These standards specify the methods and criteria for determining whether the glove meets the necessary performance and safety requirements.
7. The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in the context of demonstrating compliance for such a product.
8. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device. The specifications used to design and manufacture the gloves would be based on the requirements of the ASTM standards, and their performance is verified through testing against those standards.
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Image /page/0/Picture/1 description: The image shows the logo for Ansell Professional Healthcare. The word "Ansell" is in large, bold, black letters, with a curved line underneath. Below that, the words "PROFESSIONAL HEALTHCARE" are in smaller, black letters.
NOV 1 3 2002
1875 Harsh Ave. S.E. • P.O. Box 550 Massillon, OH 44648-0550 U.S.A. 330.833.2811 / 800.321.9752 U.S.A. 330.833.5991 Fax ansellhealthcare.com
Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol Ansell Healthcare Products Inc. 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: 330-833-2811 Fax: 330-833-6501
- [1] Summary
- Ansell Healthcare Products Inc. [2] 1875 Harsh Avenue SE Massillon, Ohio 44646
James R. Chatterton Contact: Telephone: 330-833-2811 Fax: 330-833-6501
September 18, 2002
- Trade Name: Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and [3] Glycerol Common Name: Examination Gloves Classification Name: Glove, Patient Examination, Latex
- Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol [4] meet all of the requirements of ASTM D 3578-01a22.
- [રી Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol meet all the current specifications for ASTM D 3578-01a €2 Rubber Examination Gloves.
- [[]] Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol are non-sterile disposable devices intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
- [7] Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standard |
|---|---|
| Dimensions | Meets ASTM D 3578-01a€2 |
| Physical Properties | Meets ASTM D 3578-01a€2 |
| Freedom from holes | Meets ASTM D 3578-01a€2Meets ASTM D 5151-99 |
| Powder-Free | Meets ASTM D 3578-01a€2Not more than 2 mg residue by mass perglove. |
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Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol Ansell Healthcare Products Inc. 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: 330-833-2811 330-833-6501 Fax:
Biocompatability Primary Skin Irritation in Rabbits Guinea Pig Sensitization
Passes Passes
- (8) The performance test data of the non clinical tests are the same as mentioned immediately above.
- Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process. ləl
- [10] It is concluded that the Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol (Modified) are as safe, as effective, and perform as well as the glove performance standards referenced above and therefore meet:
ASTM listed standards, FDA hole requirements, and labeling claims for the product.
- [11] This summary will include any other information reasonably deemed necessary by the FDA.
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Image /page/2/Picture/0 description: The image shows a partial view of a document or logo. On the left, there's a stylized graphic that appears to be a series of curved lines or shapes, possibly representing waves or a stylized symbol. To the right of this graphic, the word "DEPART" is visible, suggesting that the document or logo is related to a department or organization with a name starting with these letters. The overall image is cropped, so the full context and meaning are not immediately clear.
NOV 13 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. James R. Chatterton Vice President Regulatory Ansell Healthcare Products, Incorporated 1875 Harsh Avenue, S.E. · Massillon, Ohio 44646-7199
Re: K023153
Trade/Device Name: Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol (Green) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: 80 LYY Dated: October 25, 2002 Received: October 28, 2002
Dear Mr. Chatterton:
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. Chatterton
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 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.
for Susan Penner
Timothy A. Ullatowski
Timothy A. Ulatowski 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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Number (if known)
KC 23153
Device Name
Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol (Green)
Indications for Use
Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol intended for medical purposes that is worn on the examiners hand 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
Clins. Ps
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number. K023153
§ 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.