(13 days)
Micro-Touch® Powder Free Latex Surgical Gloves (Protein Label Claim) are sterile disposable devices intended to be worn by operating room personnel to protect surgical wounds from contamination.
Micro-Touch® Powder Free Latex Surgical Gloves (Protein Label Claim) meet all the current specifications for ASTM D 3577-00, Rubber Surgical Gloves, Type 1.
The provided text describes the acceptance criteria and a study for the "Micro-Touch® Powder Free Latex Surgical Gloves (Protein Label Claim)". However, it's important to note that this is a 510(k) submission from 2001 for a physical medical device (surgical gloves), not an AI/ML software device. Therefore, many of the requested fields (like sample size for test/training set, number of experts for ground truth, adjudication method, MRMC study, standalone performance) are not applicable to this type of submission.
Here's a breakdown of the information that can be extracted or inferred from the document based on the provided categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (Reference) |
|---|---|
| Dimensions (ASTM D 3577-00) | Meets ASTM D 3577-00 (Non-clinical test data) |
| Physical Properties (ASTM D 3577-00) | Meets ASTM D 3577-00 (Non-clinical test data) |
| Freedom from holes (ASTM D 3577-00) | Meets ASTM D 3577-00 (Non-clinical test data) |
| Freedom from holes (ASTM D 5151-99) | Meets ASTM D 5151-99 (Non-clinical test data) |
| Biocompatability (Primary Skin Irritation in Rabbits Test) | Passes Primary Skin Irritation in Rabbits Test (Non-clinical test data) |
| Biocompatability (Guinea Pig Sensitization Test) | Passes Guinea Pig Sensitization Test (Non-clinical test data) |
| Protein Label Claim (≤ 50 micrograms total water extractable protein per gram) | Meets ASTM D 5712-99 (specifically, "contains 50 micrograms or less of total water extractable protein per gram") (Non-clinical test data) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable for this type of medical device submission. The "tests" refer to standardized physical and chemical property tests, not a "test set" in the context of an AI/ML algorithm. The ASTM standards specify testing methodologies and sample sizes for quality control, but this document summarizes the results of meeting those standards.
- Data Provenance: Not applicable in the AI/ML sense. The non-clinical test data was generated by Ansell Healthcare Products Inc. to demonstrate adherence to established ASTM standards. The specific country of origin for the test execution is not mentioned, and it's not "retrospective or prospective" data in the way a clinical study would be.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. For this type of physical device, ground truth is established by objective measurements against recognized industry standards (ASTM). No human expert consensus for "ground truth" (in the AI/ML sense) is involved.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are relevant for subjective interpretations, often in clinical imaging or diagnostics. The tests for surgical gloves are objective, laboratory-based measurements against defined 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
- No. An MRMC study is not relevant for this physical medical device. This type of study assesses the impact of AI on human reader performance, which doesn't apply to surgical gloves.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical product (surgical gloves), not an algorithm. Therefore, "standalone performance" of an algorithm is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" in this context is defined by established objective measurements and performance criteria specified in the referenced ASTM standards (ASTM D 3577-00 for dimensions, physical properties, freedom from holes; ASTM D 5151-99 for freedom from holes; ASTM D 5712-99 for protein analysis) and biocompatibility tests (Primary Skin Irritation in Rabbits Test, Guinea Pig Sensitization Test). This is a form of objective standard compliance.
8. The sample size for the training set
- Not applicable. There is no "training set" for physical medical devices of this nature. This concept is specific to machine learning algorithms.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, this question is irrelevant.
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Ansell
KD 13603
ANSELL HEALTHCA
NOV 1 3 2001
KO 13 Colors Harsh Ave. S.E.B. Books Co., 5.50
18 Stations Massillors S.E.B. Books 15.5.50
Massillars Massillors Marsh Ave. 5.5.6.60 15.5.5.0
130.8330.883.9911.9752.6.3.5.5.5 330.833.2811 / 800.321.9752 U.S.A. 330.833.5991 Fax
ansellhealthcare.com
Micro-Touch® Powder Free Latex Surgical Gloves (Protein Label Claim)
| 510(k) Summary | |
|---|---|
| Page 1 of 2 | |
| Submitter: | Ansell Healthcare Products Inc. Inc.1875 Harsh Avenue SEMassillon, Ohio 44646 |
| Contact: | James R. Chatterton |
| Telephone: | 330-833-2811 x297 |
| Fax: | 330-833-6501 |
| Date of Preparation: | October 16, 2001 |
| Trade Name: | Micro-Touch® Powder Free Latex Surgical Gloves |
| Common Name: | Surgical Gloves |
| Classification Name: | Surgeon's Glove |
| Legally Marketed Device to Which Equivalency Is Being Claimed: | Micro-Touch® Powder Free Latex Surgical Gloves, cleared for the market under 510(k) K961632, cleared July 2, 1996. |
| Device Description: | Micro-Touch® Powder Free Latex Surgical Gloves (Protein Label Claim) meet all the current specifications for ASTM D 3577-00, Rubber Surgical Gloves, Type 1. |
| Intended Use: | Micro-Touch® Powder Free Latex Surgical Gloves (Protein Label Claim) are sterile disposable devices intended to be worn by operating room personnel to protect surgical wounds from contamination. |
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Micro-Touch® Powder Free Latex Surgical Gloves (Protein Label Claim) Ansell Healthcare Products Inc. 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: 330-833-2811 330-833-6501 Fax: Page 2 of 2
Micro-Touch® Powder Free Latex Surgical Gloves (Protein Label Claim) are [7] Summary of equivalent to the predicate device in that they have the same following Technological Characteristics technological characteristics. Compared to Predicate Device
| Characteristic | Standard | ||
|---|---|---|---|
| Dimensions | Meets ASTM D 3577-00 | ||
| Physical Properties | Meets ASTM D 3577-00 | ||
| Freedom from holes | Meets ASTM D 3577-00 | ||
| Meets ASTM D 5151-99 | |||
| Biocompatability | Passes Primary Skin Irritation inRabbits Test | ||
| Passes Guinea Pig SensitizationTest | |||
| Micro-Touch® Powder Free Latex Surgical Gloves (Protein Label Claim)have the additional characteristic: | |||
| Protein Label Claim: This latex glovecontains 50 micrograms or less oftotal water extractable protein pergram | Meets ASTM D 5712-99 StandardTest Method for Analysis of Proteinin Natural Rubber and Its Products | ||
| [8] | Brief Discussion ofNon-clinical Tests | Non-clinical test data (see [7] above) indicate that the product meets allapplicable ASTM standards, and FDA requirements for biocompatibility andprotein label claim. | |
| [9] | Clinical Tests: | Clinical data are not needed for medical gloves or for most devices clearedby the 510(k) process. | |
| [10] | ConclusionsDrawn from Non-clinical Tests: | It is concluded that the Micro-Touch® Powder Free Latex Surgical Gloves(Protein Label Claim) are as safe and effective, and perform as well as thepredicate product. They meet ASTM listed standards, and FDArequirements for holes and protein labeling claims. | |
| [11] | Other InformationDeemedNecessary by FDA | This summary will include any other information reasonably deemednecessary by the FDA. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 2001
Mr. James R. Chatterton Vice President Regulatory Ansell Healthcare Products, Incorporated 1875 Harsh Avenue, SE Massillon, Ohio 44646
Re: K013603
Trade/Device Name: Micro Touch ® Powder Free Latex Surgical Gloves with Protein Content Labeling Claim ( 50 Micrograms or Less ) Regulation Number: 878.4460 Regulation Name: Surgeon's Glove, Powder-Free Regulatory Class: I Product Code: KGO Dated: October 15, 2001 Received: October 31, 2001
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.
Please be advised that FDA's issuance of a substantial equivalence determination does no
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mean that FDA has made a determination that your device complies with other requirements mean that IDA has made a deceminations administered by other Federal agencies. of the Act of ally I cocial sunates and registered to: but not limited to: registration You must confirst (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Pat 807), laooling (21 CFR Part 820), and if 11 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 310(K) premiered 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 If you desire specific ad rios 100 for in vitro diagnostic devices), please contact the and additionally 21 CF R F at 809119 118. Additionally, for questions on the promotion and Office of Confightance wee, 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 notification (210) 11 at 00797). Village - Small Manufacturers, International and the Act may be obtained from the Driver of each of each or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours
Timo 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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NOV 1 3 2001
Attachment 2
Indications for Use Statement
| 510(k) Number (if known) | K013603 |
|---|---|
| Device Name | Micro-Touch® Powder Free Surgical Gloves WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
| Indications for Use | Micro-Touch® Powder Free Latex Surgical Gloves are to be worn by operating room personnel to protect a surgical wound from contamination. |
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 _
Ques. Lin
'Division Sign-Off) Control of Dental, Infection Control, - General Hospital Device r . Ope Number _
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).