(50 days)
Not Found
Not Found
No
The device is a standard patient examination glove, and the summary focuses on material properties and performance against ASTM standards and watertight tests, with no mention of AI or ML.
No
The device, a patient examination glove, is intended for preventing contamination, not for treating a disease or condition.
No
The device is a patient examination glove, intended to prevent contamination. It does not perform any diagnostic function.
No
The device description clearly states it is a physical glove made of nitrile latex, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "patient examination glove...worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used during physical examination, not a device used to examine specimens in vitro (outside of the body) to diagnose or monitor a condition.
- Device Description: The description focuses on the physical properties and standards met by the glove (nitrile latex, Class I, ASTM standards, watertight test). This aligns with a medical device used for protection and barrier function, not an IVD which would typically involve reagents, assays, or analytical components.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on testing in vitro.
Therefore, based on the provided text, this device is a medical device used for barrier protection during patient examination, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
LZA
Device Description
COMFIT POWDER FREE BLUE NITRILE EXAMNATION GLOVE, STERILE, Class I nitrile latex patient examination's glove, powder free. It meets ASTM Standard D 3578-99 for all properties with the exception of ultimate elongation before the aging test.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare personnel and similar personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data of gloves to ASTM D 3578-99 standard and FDA 1000 ml watertight test.
Key results:
- Watertight (1000 ml): Pass based on 1) Single Sampling Plan, G-I, AQL 2.5, 2) Multiple Sampling Plan, G-II, AQL 4.0
- Length (mm): S 248, M 245, L 245
- Palm Width (mm): S 84, M 94, L 106
- Single Wall Thickness Finger: 0.19 mm
- Single Wall Thickness Palm: 0.13 mm
- Before Aging: Tensile Strength (MPa) 25.01, Ultimate Elongation (%) 674
- After Aging: Tensile Strength (MPa) 25.32, Ultimate Elongation (%) 649
- Residual Powder: Less than 2mg/glove
The performance test data of device as shown above indicate that these nitrile gloves meet requirements of ASTM D 3578-99 Standard Specification for Rubber Examination Gloves with the exception of ultimate elongation before the aging test.
Based on the test results, these nitrile gloves meet the requirement of FDA's 1000 ml Watertight Test and ASTM D 3578-99 Standard Specification 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 fro tensile strength.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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Image /page/0/Picture/1 description: The image shows the letters "WRP" in a bold, sans-serif font. The letters are arranged horizontally, with "W" on the left, "R" in the middle, and "P" on the right. The letters are black, and the background is white. The letters are slightly rounded.
WRP Asia Pacific Sdn Bhd
K93313
NOV 2 3 1999
BER PRODUCTS (M) SON BHD
ATTACHMENT 3 (Revised)
Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA
TEL +60-3-846 1486 FAX +60-3-846 1485/1557 EML mktgwrp@ibm.net URL www.wrpworld.com
CONTACT PERSON : Y. W. CHOW
510(k) SUMMARY
-
- Trade Name COMFIT POWDER FREE BLUE NITRILE EXAMNATION : GLOVE, STERILE
-
- Common Name Examination Gloves :
- Patient Examination Glove 3. Classification Name :
4. Substantial Equivalence :
Class I nitrile latex patient examination's glove, 80 LZA, powder free. It meets ASTM Standard D 3578-99 for all properties with the exception of ultimate elongation before the aging test.
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.
Page 1 of 3
Gloves For All Reasons™
1
Image /page/1/Picture/0 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in a bold, sans-serif font, with the words "WRP Asia Pacific Sdn Bhd" to the right of the letters. Below the company name, it says "FORMERLY KNOWN AS WEMBLEY RUBBER PRODUCTS (M) SDN BHD" in a smaller font.
1 4 7 8 1 7 V
6. Summary of Performance Data
Performance data of gloves to ASTM D 3578-99 standard and FDA 1000 ml watertight test.
| TEST | ASTM D 3578-99 | COMFIT Powder Free Blue Nitrile Examination Glove, Sterile - refer to Attachment 8 of Device Test Report of Compliance |
|---|---|---|
| 1. Watertight (1000 ml) | G-I, AQL 2.5 | Pass based on |
- Single Sampling Plan, G-I,
AQL 2.5, - Multiple Sampling Plan, G-II,
AQL 4.0 |
| 2. Length (mm)
Size | XS min 220
S min 220
M min 230
L min 230
XL - | -
248
245
245
-
|
| 3. Palm Width (mm)
Size | XS 70 ± 10
S 80 ± 10
M 95 ± 10
L 111 ± 10
XL - | -
84
94
106
-
|
| 4. Single Wall Thickness
(mm)
Finger
Palm | min 0.08
min 0.08 | 0.19
0.13 |
| TEST | ASTM
D 3578-99 | COMFIT Powder Free Blue
Nitrile Examination Glove,
Sterile - refer to Attachment 8 of
Device Test Report of
Compliance |
| 1. Physical Properties | | |
| Before Aging : | | |
Page 2 of 3
2
Image /page/2/Picture/0 description: The image shows a logo with the letters "WRP" in white against a black, stylized hexagonal background. The letters are bold and sans-serif, with the "W" and "R" sharing a common vertical stroke. The hexagon has rounded corners, giving it a smooth, modern appearance. The overall design is simple and impactful, suggesting a brand identity.
- Physica
Tensile Strength (MPa)
Ultimate Elongation (%)
Tensile Strength (MPa)
Ultimate Elongation (%)
After Aging :
- Residual Powder
BRODUCTS (M) SDN BHD
25.01
674
25.32
649
Less than 2mg/glove
min 14.0
min 700
min 14.0
min 500
Less than
| ------------
and and and the commended as any and any and the defender of the defined to the define the defense with and
.
Concession Collection | ---------------
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Householder Status
.
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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 requirements of ASTM D 3578-99 Standard Specification for Rubber Examination Gloves with the exception of ultimate elongation before the aging test.
8. Conclusion
Based on the test results, these nitrile gloves meet the requirement of FDA's 1000 ml Watertight Test and ASTM D 3578-99 Standard Specification 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 fro tensile strength.
Date Summary Prepared : September 22, 1999. (Amended on November 1, 1999)
3
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 1999
Mr. Yue Wah Chow Head of RA/QA WRP Asia Pacific Sdn. Bhd. Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinqqi 43900 Sepanq Selangor Darul Ehsan, Malaysia
к993313 Re : Powder-Free Blue Nitrile Examination Glove, Trade Name: Sterile Requlatory Class: I Product Code: LZA Dated: September 29, 1999 Received: October 4, 1999
Dear Mr. Chow:
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 requlations 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
4
Page 2 - Mr. Chow
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 leqally 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 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 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.fdag.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy R. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
5
ATTACHMENT 2
Applicant : WRP Asia Pacific Sdn Bhd
510(k) Number (if known) : 长993313
COMFIT POWDER FREE BLUE NITRILE EXAMINATION Device Name : GLOVE, STERILE
Indications For Use :
- The patient examination glove is a disposable device intended for medical purposes 1. 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
R Over-The-Counter Use
L. A. Cutath
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 5 . Onk) Number __