(224 days)
The gloves are intended to be worn on the hand of healthcare personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.
The 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.
Class I nitrile latex patient examination's glove, 80 LZA, powder free. It meets ASTM Standard D 3578-99 requirement for all properties with the exception of ultimate elongation.
This document describes the acceptance criteria and performance of the DERMAGRIP Powder Free Nitrile Examination Glove, Non Sterile.
1. Table of Acceptance Criteria and Reported Device Performance
| TEST | Acceptance Criteria (ASTM D 3578-99) | Reported Device Performance (DERMAGRIP Powder Free Nitrile Examination Glove, Non Sterile) |
|---|---|---|
| 1. Watertight (1000 ml) | G-1, AQL 2.5 | Pass based on: 1) Single Sampling Plan, G-I, AQL 2.5, 2) Multiple Sampling Plan, G-II, AQL 4.0 |
| 2. Length (mm) | ||
| XS | min 220 | - |
| S | min 220 | 260 |
| M | min 230 | 245 |
| L | min 230 | 248 |
| XL | - | - |
| 3. Palm Width (mm) | ||
| XS | 70 ± 10 | - |
| S | 80 ± 10 | 84 |
| M | 95 ± 10 | 95 |
| L | 111 ± 10 | 104 |
| XL | - | - |
| 4. Single Wall Thickness (mm) | ||
| Finger | min 0.08 | 0.21 |
| Palm | min 0.08 | 0.14 |
| 5. Physical Properties | ||
| Before Aging : | ||
| Tensile Strength (MPa) | min 14.0 | 29.50 |
| Ultimate Elongation (%) | min 700 | 670 |
| After Aging : | ||
| Tensile Strength (MPa) | min 14.0 | 27.45 |
| Ultimate Elongation (%) | min 500 | 583 |
| 6. Residual Powder | Less than 4mg/glove | Less than 2mg/glove |
Note regarding Ultimate Elongation: The device's ultimate elongation (before aging: 670%; after aging: 583%) did not meet the ASTM D 3578-99 standard (min 700% before aging, min 500% after aging). However, the document states that the gloves "meet ASTM D 3578-99 requirement for all properties with the exception of ultimate elongation" and "The performance test data of device as shown above indicate that these nitrile gloves meet ASTM D'3578-99 Standard Specification for Rubber Examination Gloves with the exception of ultimate elongation." This implies that the FDA still considered the device substantially equivalent despite this specific deviation.
The following information is not available in the provided text:
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document mentions "refer to Attachment 8 of Device Test Report of Compliance" for the performance data, but Attachment 8 is not provided. Therefore, the specific sample sizes for each test are not detailed, nor is the data provenance (country, retrospective/prospective).
-
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 information is not applicable as the tests described are physical and chemical property tests of a medical device (examination gloves), not diagnostic interpretations requiring expert consensus.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable for physical and chemical property testing. The results are typically objectively measured and evaluated against a standard. The watertight test does mention "Single Sampling Plan, G-I, AQL 2.5" and "Multiple Sampling Plan, G-II, AQL 4.0," which are statistical sampling methods, not expert adjudication.
-
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
- This information is not applicable as the device is an examination glove, not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable as the device is an examination glove, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device is established by the specifications defined in industry standards, specifically ASTM D 3578-99 Standard Specification for Rubber Examination Gloves and FDA's 1000ml Watertight Test. The performance data is objectively measured against these established physical and chemical criteria.
-
The sample size for the training set
- This information is not applicable as the device is an examination glove, not a machine learning model that requires a training set.
-
How the ground truth for the training set was established
- This information is not applicable for the same reason as above.
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Image /page/0/Picture/1 description: The image shows the letters "WRP" in white against a black background. The letters are bold and slightly stylized, with the "W" appearing larger than the "R" and "P". The overall design is simple and eye-catching, possibly representing a logo or abbreviation.
WRP Specialty Products Sdn Bhd
OCT 18 1999
ATTACHMENT 3 (Revised)
Lot 11, Jalan 2, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang Selangor Darul Ehsan,
EL +60-3-846 2055 +60-3-846 1437 URL www.wrpworld.com
MALAYSIA
CONTACT PERSON : C. H. KHOO
ID=+6038461485
510(k) SUMMAR
- DERMAGRIP FREE NITRILE POWDER 1. Trade Name EXAMINATION GLOVE, NON STERILE
- Examination Gloves 2. Common Name :
-
- Classification Name : Patient Examination Glove
-
- Substantial Equivalence :
Class I nitrile latex patient examination's glove, 80 LZA, powder free. It meets ASTM Standard D 3578-99 requirement for all properties with the exception of ultimate elongation.
5. Intended Use of Device :
The gloves are intended to be worn on the hand of healthcare personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.
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f the WRP Group of Companie
Gloves For All Reasons™
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WRP Specialty Products Sdn Bhd 1 1 2 7 1 3 V
6. Summary of Performance Data
Performance data of gloves to ASTM D 3578-99 standard and FDA 1000 ml watertight test.
| TEST | ASTMD 3578-99 | DERMAGRIP Powder FreeNitrile Examination Glove, NonSterile - refer to Attachment 8of Device Test Report ofCompliance | |
|---|---|---|---|
| 1. Watertight (1000 ml) | G-1, AQL 2.5 | Pass based on1) Single Sampling Plan, G-I,AQL 2.5,2) Multiple Sampling Plan, G-II,AQL 4.0 | |
| 2. Length (mm) | |||
| Size | XSSMLXL | min 220min 220min 230min 230- | -260245248- |
| 3. Palm Width (mm) | |||
| Size | XSSMLXL | $70 \pm 10$$80 \pm 10$$95 \pm 10$$111 \pm 10$- | -8495104- |
| 4. Single Wall Thickness (mm) | |||
| Finger | min 0.08 | 0.21 | |
| Palm | min 0.08 | 0.14 |
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Gloves For All Reasons™
A member of the WRP Group of Companies
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P - 1 1
WRP Specialty Products Sdn Bhd 1 1 1 7 1 2 V
| TEST | ASTMD 3578-99 | DERMAGRIP Powder FreeNitrile Examination Glove,Non Sterile - refer toAttachment 8 of Device TestReport of Compliance |
|---|---|---|
| 5. Physical Properties | ||
| Before Aging : | ||
| Tensile Strength (MPa) | min 14.0 | 29.50 |
| Ultimate Elongation (%) | min 700 | 670 |
| After Aging : | ||
| Tensile Strength (MPa) | min 14.0 | 27.45 |
| Ultimate Elongation (%) | min 500 | 583 |
| 6. Residual Powder | Less than4mg/glove | Less than 2mg/glove |
7. Substantial Equivalence based on Assessment of Non-Clinical Performance Data
The performance test data of device as shown above indicate that these nitrile gloves meet ASTM D'3578-99 Standard Specification for Rubber Examination Gloves with the exception of ultimate elongation.
8. Conclusion
Based on the test results, these nitrile gloves meet the requirement of FDA's 1000ml Watertight Test and ASTM D 3578-99 requirement for tensile strength. Our in-house specifications for tensile strength is minimum 15.5 MPa and test results exceed the in-house specifications and ASTM D 3578-99 requirement for tensile strength,
Date Summary Prepared : March 25, 1999 (First amendment on May 24, 1999) (Second amendment on July 20, 1999) (Third amendment on October 7, 1999)
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Gloves For All Reasons™
of the WRP Broup of Componie
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines extending from its head, representing the department's mission to protect and promote the health and well-being of Americans.
Public Health Service
OCT 18 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Chenq Hean Khoo Sr. Manager, Regulatory/Environmental Management WRP Specialty Products Sdn Bhd Lot 11, Jalan 2, Kawasan Perusahaan Bandar Baru Salak Tinggi 43900 Sepang Selanqor Darul Ehsan, Malaysia
Re : K990752 Dermagrip Powder Free Blue Nitrile Trade Name: Examination Glove, Non Sterile Regulatory Class: I Product Code: LZA July 20, 1999 Dated: Received: July 28, 1999
Dear Mr. Khoo:
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 The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in
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Page 2 - Mr. Khoo
the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 requlation 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,
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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ATTACHMENT 2
Applicant : WRP Specialty Products Sdn. Bhd.
K990752 510(k) Number (if known) : : __
DERMAGRIP POWDER FREE NITRILE EXAMINATION Device Name : GLOVE, NON STERILE ( Blue
Indications For Use :
- The patient examination glove is a disposable device intended for 1. medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use
Qiin S. him
(Division Sign-Off) Division of Dental, Infection and General Hospita 510(k) Number
§ 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.