(46 days)
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Not Found
No
The device description and performance studies focus solely on the physical properties and barrier function of a standard examination glove, with no mention of AI/ML capabilities or data processing.
No.
The device (a patient examination glove) is intended to prevent contamination between healthcare personnel and patients, not to treat a disease or condition.
No
Explanation: The device is a patient examination glove, intended to prevent contamination between explainer and patient. It does not provide any diagnosis of medical conditions.
No
The device description and performance studies clearly indicate this is a physical medical device (examination gloves) and there is no mention of any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are for preventing contamination between healthcare personnel and patients/their environment. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical properties and standards met for a glove (ASTM D 3578-99, watertightness). There is no mention of analyzing samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, genes, pathogens, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is a medical device, specifically a patient examination glove, but its purpose is protective and preventative, not diagnostic.
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 NITRILE EXAMINATION GLOW, STERILE
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hand or finger
Indicated Patient Age Range
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Intended User / Care Setting
healthcare personnel and similar personnel
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Performance data of gloves to ASTM D 3578-99 standard and FDA 1000 ml watertight test.
TEST | ASTM D 3578-99 | COMFIT Powder Free 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 1) Single Sampling Plan, G-I, AQL 2.5, 2) Multiple Sampling Plan, G-II, AQL 4.0 |
2. Length (mm) | ||
Size | ||
XS | min 220 | - |
S | min 220 | 248 |
M | min 230 | 250 |
L | min 230 | 260 |
XL | - | - |
3. Palm Width (mm) | ||
Size | ||
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 |
TEST | ASTM D 3578-99 | COMFIT Powder Free Nitrile Examination Glove, Sterile - refer to Attachment 8 of Device Test Report of Compliance |
5. Physical Properties | ||
Before Aging : Tensile Strength (MPa) | min 14.0 | 23.88 |
Ultimate Elongation (%) | min 700 | 669 |
After Aging : Tensile Strength (MPa) | min 14.0 | 20.48 |
Ultimate Elongation (%) | min 500 | 668 |
6. Residual Powder | Less than 4mg/glove | 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 inhouse 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.
Key Metrics
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Predicate Device(s)
Not Found (The document states "Substantial Equivalence : 4. 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." but does not provide a K/DEN number for a predicate device.)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/0 description: The image shows the logo of WRP Asia Pacific Sdn Bhd, formerly known as Wembley Rubber Products. The image also contains the number K993311 and the date NOV 19 1999. The logo consists of the letters WRP in a black oval shape. The text "WRP Asia Pacific Sdn Bhd" is written in a bold, sans-serif font.
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
- COMFIT POWDER FREE NITRILE EXAMINATION 1. Trade Name : GLOVE, STERILE
- Examination Gloves 2. Common Name :
- Patient Examination Glove 3. Classification Name :
Substantial Equivalence : 4.
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
1
Image /page/1/Picture/0 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo includes the letters "WRP" in bold, white font inside of a black oval. Below the company name is the text "FORMERLY KNOWN AS WEMBLEY RUBBER PRODUCTS (M) SDN BHD" and the number "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 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 | 248 |
| M | min 230 | 250 |
| L | min 230 | 260 |
| XL | - | - |
| 3. Palm Width (mm) | | |
| Size | | |
| XS | $70 \pm 10$ | - |
| S | $80 \pm 10$ | 84 |
| M | $95 \pm 10$ | 95 |
| L | $111 \pm 10$ | 104 |
| XL | - | - |
| 4. Single Wall Thickness
(mm) | | |
| Finger | min 0.08 | 0.21 |
| Palm | min 0.08 | 0.14 |
| TEST | ASTM D 3578-99 | COMFIT Powder Free Nitrile Examination Glove, Sterile -
refer to Attachment 8 of Device Test Report of Compliance |
| 5. Physical Properties | | |
| Before Aging : | | |
| Tensile Strength (MPa) | min 14.0 | 23.88 |
| Ultimate Elongation (%) | min 700 | 669 |
| After Aging : | | |
| Tensile Strength (MPa) | min 14.0 | 20.48 |
| Ultimate Elongation (%) | min 500 | 668 |
| 6. Residual Powder | Less than
4mg/glove | Less than 2mg/glove |
2
Image /page/2/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.
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 inhouse 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 : September 22, 1999 (Amended on October 27, 1999)
3
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles a human figure or a flame, composed of three curved lines that overlap and flow together.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 1999
Mr. Yue Wah Chow Head of RA/QA WRP Asia Pacific Sdn. Bhd. Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi 43900 Sepang Selangor Darul Ehsan, Malaysia
Re: K993311 Powder-Free Nitrile Examination Glove, Trade Name: Sterile Regulatory Class: I Product Code: LZA September 29, 1999 Dated: October 4, 1999 Received:
Dear Mr. Chow:
We have reviewed your Section 510(k) notification of intent to we have referenced above and we have determined the market the acreatially 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) regulation (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 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 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 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.fdaf.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowsk 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.
K993311 510(k) Number (if known) :
COMFIT POWDER FREE NITRILE EXAMINATION Device Name : GLOVE, STERILE
Indications For Use :
- The patient examination glove is a disposable device intended for medical 1. 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)
Over-The-Counter Use OR
Olin S. Lin
َ ivision Sign-Off) Colsion of Dental, Infection Control, · General Hospital D ಿ(k) Number _