(221 days)
Not Found
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 or ML capabilities.
No
The primary function of the device is to prevent contamination between healthcare personnel and patients, acting as a barrier rather than directly treating or mitigating a disease or condition.
No
The device is a patient examination glove, intended to prevent contamination between healthcare personnel and patients. It does not perform any diagnostic functions.
No
The device is a physical glove made of nitrile latex, not software. The description focuses on material properties and physical performance tests.
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 function.
- Device Description: The description focuses on the material (nitrile latex), class (Class I), and physical properties (thickness, strength, elongation). These are characteristics of a barrier device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing information for diagnosis.
- Performance Studies: The performance studies focus on physical properties and watertightness, which are relevant to the barrier function of a glove. They do not involve any diagnostic metrics.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This description does not align with the function of a patient examination glove.
N/A
Intended Use / Indications for Use
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Not Found
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
Not Found
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): XS: 243, S: 244, M: 246, L: -, XL: - (device length values)
- Palm Width (mm): XS: 84, S: 94, M: 104, L: -, XL: - (device palm width values)
- Single Wall Thickness (mm): Finger: 0.22, Palm: 0.13
- Physical Properties:
Before Aging:
Tensile Strength (MPa): 22.83
Ultimate Elongation (%): 534
After Aging:
Tensile Strength (MPa): 23.25
Ultimate Elongation (%): 491 - Residual Powder: Less than 2mg/glove
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
I'm not sure . . .
Lot 17, Jalan 2, Kawasan Perusahaan Bandar Baru Salak Tinggi,
3900 Sepang. Selandor Darul Ehsan
+60-3-846 1437 URL www.wrpworld.com
WRP Specialty Products Sdn Bhd
OCT 15
ATTACHMENT 3 (Revised)
CONTACT PERSON : C. H. KHOO
510(k) SUMMARY
-
- Trade Name DERMAGRIP POWDER FREE BLUE NITRILE : EXAMINATION GLOVE, NON 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 meats 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
Gloves For All Reasons™
of the WRD Group of Companie
1
Image /page/1/Picture/2 description: The image shows the logo for WRP Specialty Products Sdn Bhd. The logo consists of the letters "WRP" in a bold, black font, enclosed in a black hexagon. To the right of the logo is the company name, "WRP Specialty Products Sdn Bhd," also in a bold, black font. The text is aligned horizontally.
אניינג ונ
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 Blue
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
min 220
S
min 220
M
min 230
L
min 230
XL
-
| -
243
244
246
-
|
| 3. Palm Width (mm) | | |
| Size | XS
$70 \pm 10$
S
$80 \pm 10$
M
$95 \pm 10$
L
$111 \pm 10$
XL
- | -
84
94
104 -
|
| 4. Single Wall Thickness (mm) | | |
| Finger | min 0.08 | 0.22 |
| Palm | min 0.08 | 0.13 |
Page 2 of 3
Gloves For All Reasons™
a matriber of the WRP Group of Campenias
2
Image /page/2/Picture/0 description: The image shows the logo for WRP Specialty Products Sdn Bhd. The logo consists of the letters "WRP" in a bold, black font inside of a black hexagon. To the right of the logo is the company name, "WRP Specialty Products Sdn Bhd", also in a bold, black font. Below the company name is the number 1117184.
| TEST | ASTM D 3578-99 | DERMAGRIP Powder Free
Blue 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 | 22.83 |
| Ultimate Elongation (%) | min 700 | 534 |
| After Aging : | | |
| Tensile Strength (MPa) | min 14.0 | 23.25 |
| Ultimate Elongation (%) | min 500 | 491 |
| 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 amendement on August 18, 1999) (Second amendment on October 7, 1999)
Page 3 of 3
Gloves For All Reasons™
of the WRP Group of Companies
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 5 1999
Mr. Cheng Hean Khoo Sr. Manager, Regulatory/Environmental Management WRP Specialty Products Sdn Bhd Lot 11, Jalan 2, Kawasan Perusahaan Bandar Baru Salak Tinggi 43900 Sepang Selangor Darul Ehsan, Malaysia
Re : K990750 Trade Name: Dermagrip Powder Free Blue Nitrile Examination Glove, Non Sterile Regulatory Class: I Product Code: LZA Dated: August 19, 1999 Received: August 23, 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 of the Act. The general controls provisions 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. ਸੋ 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 regulation may result in regulatory 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 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,
Susan Punner
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.
K 99075D 510(k) Number (if known) : ___________________________________________________________________________________________________________________________________________________
Device Name : DERMAGRIP POWDER FREE BLUE _ NITRILE EXAMINATION GLOVE, NON STERILE
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)
Over-The-Counter Use OR
Qien S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number .