(224 days)
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Not Found
No
The summary describes a standard medical glove and provides performance data based on physical properties and watertightness, with no mention of AI or ML.
No
The device is a glove intended to prevent contamination between healthcare personnel and patients; it does not treat or cure any condition.
No
The device is a patient examination glove, intended to prevent contamination. It does not diagnose any condition or disease. The performance studies focus on the physical properties and integrity of the glove itself.
No
The device description clearly states it is a "Class I nitrile latex patient examination's glove," which is a physical hardware device. The summary focuses on physical properties and performance tests related to the glove's material and construction, not software functionality.
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 gloves are for preventing contamination between healthcare personnel and patients/environment. This is a barrier function, not a diagnostic one.
- Device Description: The description focuses on the material (nitrile latex) and physical properties of the glove, which are relevant to its barrier function.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Performance Studies and Key Metrics: The performance studies and metrics are related to the physical integrity and barrier properties of the glove (watertightness, strength, elongation, thickness), not diagnostic accuracy.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This device does not fit that description.
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 (comma separated list FDA assigned to the subject device)
LZA
Device Description
DERMAGRIP FREE NITRILE POWDER EXAMINATION GLOVE, NON STERILE
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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
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
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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.
1. Watertight (1000 ml)
- ASTM D 3578-99: G-1, AQL 2.5
- DERMAGRIP Powder Free Nitrile Examination Glove, Non Sterile: 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, S, M, L, XL
- ASTM D 3578-99: min 220 (XS, S), min 230 (M, L), - (XL)
- DERMAGRIP Powder Free Nitrile Examination Glove, Non Sterile: - (XS), 260 (S), 245 (M), 248 (L), - (XL)
3. Palm Width (mm)
- Size: XS, S, M, L, XL
- ASTM D 3578-99: 70 +/- 10 (XS), 80 +/- 10 (S), 95 +/- 10 (M), 111 +/- 10 (L), - (XL)
- DERMAGRIP Powder Free Nitrile Examination Glove, Non Sterile: - (XS), 84 (S), 95 (M), 104 (L), - (XL)
4. Single Wall Thickness (mm)
- Finger: min 0.08 (ASTM D 3578-99), 0.21 (DERMAGRIP)
- Palm: min 0.08 (ASTM D 3578-99), 0.14 (DERMAGRIP)
5. Physical Properties
- Before Aging :
- Tensile Strength (MPa): min 14.0 (ASTM D 3578-99), 29.50 (DERMAGRIP)
- Ultimate Elongation (%): min 700 (ASTM D 3578-99), 670 (DERMAGRIP)
- After Aging :
- Tensile Strength (MPa): min 14.0 (ASTM D 3578-99), 27.45 (DERMAGRIP)
- Ultimate Elongation (%): min 500 (ASTM D 3578-99), 583 (DERMAGRIP)
6. Residual Powder
- ASTM D 3578-99: Less than 4mg/glove
- DERMAGRIP Powder Free Nitrile Examination Glove, Non Sterile: Less than 2mg/glove
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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.
Page 1 of 3
f the WRP Group of Companie
Gloves For All Reasons™
1
Image /page/1/Picture/3 description: The image shows a logo with the letters "WRP" in white against a black background. The letters are bold and sans-serif. The background is an irregular hexagon shape with rounded corners.
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 | ASTM
D 3578-99 | DERMAGRIP Powder Free
Nitrile Examination Glove, Non
Sterile - refer to Attachment 8
of Device Test Report of
Compliance | |
|-------------------------------|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| 1. Watertight (1000 ml) | G-1, 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
S
M
L
XL | min 220
min 220
min 230
min 230
-
| -
260
245
248
- |
| 3. Palm Width (mm) | | | |
| Size | XS
S
M
L
XL | $70 \pm 10$
$80 \pm 10$
$95 \pm 10$
$111 \pm 10$ -
| -
84
95
104
- |
| 4. Single Wall Thickness (mm) | | | |
| Finger | | min 0.08 | 0.21 |
| Palm | | min 0.08 | 0.14 |
Page 2 of 3
Gloves For All Reasons™
A member of the WRP Group of Companies
2
P - 1 1
WRP Specialty Products Sdn Bhd 1 1 1 7 1 2 V
| TEST | ASTM
D 3578-99 | DERMAGRIP Powder Free
Nitrile Examination Glove,
Non Sterile - refer to
Attachment 8 of Device Test
Report 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 than
4mg/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)
Page 3 of 3
Gloves For All Reasons™
of the WRP Broup of Componie
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 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
4
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
5
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