(105 days)
The Pure Advantage Nitrile Surgical Glove, Hypoallergenic is "a disposable device intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination" (21CFR 878.4460).
The Pure Advantage Nitrile Hypoallergenic Surgical glove is a nitrile rubber product manufactured in accordance with the requirements of ASTM D3577 (Typell) and ASTM D5151 requirements.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Pure Advantage Nitrile Hypoallergenic Surgical Glove.
The document describes a 510(k) submission for a new surgical glove, comparing it to an existing predicate device. The studies described are primarily non-clinical and aim to demonstrate substantial equivalence, particularly regarding performance standards and safety for hypoallergenic claims.
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Acceptance Criteria (Standards) | Proposed Device Performance (Pure Advantage Nitrile Surgical Hypoallergenic) | Predicate Device Performance (Pure Advantage Nitrile Surgical) |
|---|---|---|---|
| Performance | ASTM D 3577 [Type 2] | Meets ASTM D 3577 [Type 2] | Meets ASTM D 3577 [Type 2] |
| Water Tightness | ASTM D 5151 | Meets ASTM D 5151 | Meets ASTM D 5151 |
| Safety | Passing Rabbit Irritation Test | Passes | Passes |
| Guinea Pig Maximization | Passing Guinea Pig Maximization | Passes | Passes |
| Modified Draize Repeat Insult Patch Test (for Hypoallergenic Claim) | Passing (No sensitization in 200 human subjects) | Passes | Passes |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: For the Modified Draize Repeat Insult Patch Test, 200 human subjects were used.
- Data Provenance: The document does not explicitly state the country of origin for the human subjects in the Modified Draize test, but given the submitter and FDA context, it's likely U.S.-based. The study is prospective for the purpose of this submission, though the method itself is a standard clinical evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study (Modified Draize Repeat Insult Patch Test) does not typically involve "experts" establishing a ground truth in the same way an imaging study would. The ground truth is the objective physiological response of the human subjects to the glove material (i.e., whether sensitization occurs). The test is conducted and evaluated by trained personnel in a clinical setting, but the document does not specify the number or qualifications of these personnel. The assessment of "Passes" implies a qualified professional interpretation against established dermatological criteria for irritation and sensitization.
4. Adjudication Method for the Test Set
Not applicable for this type of test. The Modified Draize test involves direct observation of skin reactions by trained clinical personnel, not a consensus or adjudication process among multiple independent reviewers as seen in, for example, medical image interpretation studies.
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 comparative effectiveness study was not done. This device is a surgical glove, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this is not an AI algorithm. The performance evaluation is for a physical medical device.
7. The Type of Ground Truth Used
The ground truth for the safety tests (like the Modified Draize) is based on direct physiological responses observed in human subjects (or animal models for pre-clinical tests) according to established dermatological and toxicological protocols. For performance, the ground truth is established by objective measurements against recognized ASTM standards.
8. The Sample Size for the Training Set
There is no explicit "training set" mentioned in the context of machine learning, as this is a physical device submission. However, if interpreting "training set" as the data used to validate the product design and manufacturing process before the final testing for the submission, the document doesn't provide this detail. The safety studies explicitly mentioned for the submission used 200 human subjects for the patch test.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the AI sense, this question is not applicable. The design and manufacturing of the glove would be informed by general material science, engineering principles, and previous experience with similar products, all aiming to meet the specified ASTM standards and safety profiles. The objective "ground truth" for these ongoing processes would be adherence to the physical and chemical properties and safety profiles defined by scientific understanding and regulatory requirements.
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SUMMARY OF 510(k) Submission # K972009
- INFORMATION A.
-
- SUBMITTER'S NAME:
-
ADDRESS:
TELEPHONE NUMBER:
CONTACT PERSON:
DATE SUMMARY PREPARED.
-
- NAME OF DEVICE TRADE OR PROPRIETARY NAME:
COMMON OR USUAL NAME:
- NAME OF DEVICE TRADE OR PROPRIETARY NAME:
CLASSIFICATION NAME:
-
- PREDICATE DEVICE IDENTIFICATION NAME, NUMBER
TILLOTSON HEALTHCARE CORPORATION
- PREDICATE DEVICE IDENTIFICATION NAME, NUMBER
360 Route 101 Bedford, NH 03110 U.S.A.
(603) 472-6600
Edward Markovic
May 29, 1997
Pure Advantage Nitrile Hypoallergenic Surgical Glove
Nitrile Surgical Glove Hypoallergenic
Surgeon's Glove
- Pure Advantage Nitrile Surgical Glove K915086
-
- DESCRIPTION OF DEVICE
- a. SCIENTIFIC CONCEPTS THAT FORM THE BASIS FOR THE DEVICE: The nitrile rubber is water tight under normal conditions of use. it's tensile properties cause it to conform to the hand, allowing fine movements necessary for medical treatment. The absence of natural rubber latex in the product yields no latex protein allergens.
- b. PHYSICAL AND PERFORMANCE CHARACTERISTICS SUCH AS DESIGN, MATERIALS AND PHYSICAL PROPERTIES: The Pure Advantage Nitrile Hypoallergenic Surgical glove is a nitrile rubber product manufactured in accordance with the requirements of ASTM D3577 (Typell) and ASTM D5151 requirements.
-
- STATEMENT OF INTENDED USE, INCLUDING DESCRIPTION OF THE DISEASES OR CONDITIONS THAT THE DEVICE WILL ADDRESS
This is a disposable device, intended for medical purposes, that is worn by operating room personnel to protect a surgical wound from contamination. Hypoallergenic surgical gloves are suitable in situations where health care worker or patient allergic sensitivity may be a factor.
- EXPLANATION OF SIMILARITIES OR DIFFERENCES TO PREDICATE DEVICE
- · The proposed product is identical to the predicate product, except for the following: The proposed product is labeled :"Hypoallergenic", and is sultable for situations where a low sensitizing glove is desirable.
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SUMMARY OF SAFETY AND EFFECTIVENESS (cont.)
- IF SE DECISION BASED ON PERFORMANCE DATA B.
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- DISCUSSION OF NON-CLINICAL TESTS
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| SPECIFICATION | PROPOSEDPure AdvantageNitrile SurgicalHypoallergenic | PREDICATEPure AdvantageNitrile Surgical |
|---|---|---|
| PERFORMANCESTANDARDS | ASTM D 3577 [Type 2] | ASTM D 3577 [Type 2] |
| WATER TIGHTNESS | ASTM D 5151 | ASTM D 5151 |
| DISCUSSION OF CLINICAL TESTS | ||
| SPECIFICATIONSAFETY | PROPOSED | PREDICATE |
| RABBIT IRRITATION | Passes | Passes |
| GUINEA PIGMAXIMIZATION | Passes | Passes |
| MODIFIED DRAIZEREPEAT INSULTPATCH TEST- 200 HUMAN SUBJECTS | Passes | Passes |
| DESCRIPTION OF SUBJECTSFor the Modified Draize Repeat Insult Patch Test, 200 human subjects were used. | ||
| Both the inside surface and outside surface of a medical gloveproduct, Pure Advantage | ||
| Nitrile Surgical Glove were evaluated to determine its ability to sensitize the skin of a | ||
| normal volunteer subject using an occlusive repeated insult patch study. | ||
| DISCUSSION OF SAFETY OR EFFECTIVENESS DATA OBTAINED | ||
| with specific reference to adverse effects and complications | ||
| Please see Section K-1, for a SUMMARY of the data on testing |
- of 200 Human Subjects.
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- CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE SAFETY EFFECTIVENESS, AND PERFORMANCE =/> PREDICATE PRODUCT
The Pure Advantage Nitrile Hypoallergenic Surgical Glove has been carefully compared to legally marketed devices in the predicate 510(k). The final finished product test data indicate that the proposed product meets acceptable scores in nonclinical tests, and satisfies the requirements for a safe and effective hypoallergenic medical glove.
The Pure Advantage Nitrile Hypoallergenic Surgical glove meets the ASTM D3577 (Typell) requirements and ASTM D6151 requirements.
| Pursuant to 21 C.F.R. 807.87 (j), I, Edward Markovic, Manager QA/Regulatory Affairs |
|---|
| certify that to the best of my knowledge and belief and based upon the data |
| and information submitted to me in the course of my responsibilities as the |
| Manager QA/Regulatory Affairs for TILLOTSON HEALTHCARE CORPORATION, |
| and in reliance thereupon, the data and Information submitted in this |
| premarket notification are truthful and accurate and that no facts material to a review |
| of the substantial equivalence of this device have been knowingly omitted from this |
| submission. |
submission.
Edward Markovic
Edward Markovic Manager QA/Regulatory Affairs
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and body. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP | 2 |997
Mr. Edward Markovic Quality Assurance & Regulatory Manager Tillotson Healthcare Corporation 360 Route 101 Bedford, New Hampshire 03110
K972009 Re : Pure Advantage Nitrile Hypoallergenic Trade Name: Surgical Glove Regulatory Class: I Product Code: KGO Dated: July 21, 1997 Received: July 22, 1997
Dear Mr. Markovic:
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 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
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Page 2 - Mr. Markovic
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
Please also be advised that FDA is examining whether the Modified Human Draize Test, as it is currently conducted on medical gloves, is a valid means of predicting the sensitization potential of latex or synthetic materials. If FDA finds that the test is not a scientifically sound means to predict latex or synthetic materials hypersensitivity reactions in users, then hypoallergenic claims included in labeling for medical gloves may be considered misleading, and we will move to have the claim removed from labeling for all medical gloves.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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" (21 CFR 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/dsmamain.html".
Sincerely yours,
Patrucci Cucinotta for
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):
510(k) 972009
Page 1 of 1
Device Name:
Pure Advantage Nitrile Hypoallergenic Surgical Gloves Sterile oped devel
Indications For Use:
The Pure Advantage Nitrile Surgical Glove, Hypoallergenic is "a disposable device intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination" (21CFR 878.4460).
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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | R9/2009 | ||
|---|---|---|---|
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The- Counter Use | X |
(Optional Format 1-2-96)
§ 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).