(24 days)
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Not Found
No
The device description and performance studies focus on the physical properties and barrier function of a standard examination glove, with no mention of AI or ML.
No
The intended use states that the gloves are to prevent contamination between healthcare personnel and patients, not to treat a disease or condition. They serve as a barrier, which is a preventative rather than a therapeutic function.
No
Explanation: The device, a patient examination glove, is intended to prevent contamination between healthcare personnel and patients. Its purpose is to provide a barrier, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states it is a "Class I natural rubber latex patient examination's glove," which is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Intended Use: The intended use of these gloves is to be worn on the hand to prevent contamination between healthcare personnel and patients or their environment. This is a barrier function, not a diagnostic test performed on a sample.
- Device Description: The description focuses on the physical properties and performance of the glove as a barrier (watertightness, strength, thickness, etc.).
- Performance Studies: The performance studies evaluate the glove's ability to function as a barrier (watertightness, physical properties), not its ability to detect or measure substances in a biological sample.
The information provided clearly indicates that these are patient examination gloves intended for barrier protection, which falls under the category of general medical devices, not In Vitro Diagnostics.
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)
LYY
Device Description
Class I natural rubber latex patient examination's glove, 80 LYY, powder free, protein content labeling. It meets all of the requirements of ASTM standard D3578-95.
Mentions image processing
Not Found
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
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 3578-95 and FDA 1000 ml watertight test.
Watertight (1000 ml): Pass based on 1) Single Sampling Plan, S-4, AQL 4.0, 2) Multiple Sampling Plan, GII, AQL 4.0
Length (mm): XS: 245, S: 255, M: 297, L: 249, XL: 253 (all meet or exceed min requirements)
Palm Width (mm): XS: 77, S: 81, M: 96, L: 105, XL: 114 (all within ±10 range)
Single Wall Thickness (mm): Finger: 0.36, Palm: 0.25 (both meet or exceed min requirement of 0.08)
Physical Properties - Before Aging: Tensile Strength (MPa): 28.63 (meets min 14), Ultimate Elongation (%): 962 (meets min 700)
Physical Properties - After Aging: Tensile Strength (MPa): 18.43 (meets min 14), Ultimate Elongation (%): 1007 (meets min 500)
Powder Content: below 2 mg/glove
Protein Content: below 50 microgram/gram
The performance test data of device as shown above indicate that this glove meets requirements of ASTM D 3578-95. Protein content tested on recently manufactured and accelerated aging gloves using ASTM D5712 is below 50 microgram/gram.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Watertight (1000 ml): S-4, AQL 4.0
Tensile Strength (MPa): min 14 (ASTM), 28.63 (Before Aging), 18.43 (After Aging)
Ultimate Elongation (%): min 700 (ASTM), 962 (Before Aging), min 500 (ASTM), 1007 (After Aging)
Powder Content: below 2 mg/glove
Protein Content: below 50 microgram/gram
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.
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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.
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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
4/23/99
Image /page/0/Picture/1 description: The image shows a logo with the letters "WRP" in bold, black font. The letters are stacked horizontally, with the "W" on the left, the "R" in the middle, and the "P" on the right. The letters are enclosed within a thick, black, rounded rectangle. The background of the logo is white.
WRP SPECIALTY PRODUCTS SDN BHD
(Company No: 112713-V)
11, Jalan 2, Kawasan Perusahaan Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, Malaysia. Fax: +60-3-846 1437 & 846 1482 Tel: +60-3-846 2055 & 846 1486
ATTACHMENT 3
KSS1044
CONTACT PERSON : C. H. KHOO
510(k) SUMMARY
- DERMAGRIP POWDER FREE LATEX 1. Trade Name EXAMINATION GLOVE, NON STERILE (PROTEIN CONTENT LABELING) 50 micro
- Examination Gloves 2. Common Name :
-
- Classification Name : Patient Examination Glove
4. Substantial Equivalence :
Class I natural rubber latex patient examination's glove, 80 LYY, powder free, protein content labeling. It meets all of the reguirements of ASTM standard D3578-95.
5. Description of Device :
Class I natural rubber latex patient examination's glove, 80 LYY, powder free, protein content labeling. It meets all of the requirements of ASTM standard D3578-95.
6. 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.
1
7. Summary of Performance Data :
... ...
Performance data of gloves to ASTM D 3578-95 and FDA 1000 ml watertight test.
| TEST | ASTM
D3578-95 | DERMAGRIP Powder Free
Latex Examination Glove, Non
Sterile (Protein Content
Labeling) - refer to Attachment
9 of Device Test Report of
Compliance |
|----------------------------------|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Watertight (1000
ml) | S-4, AQL 4.0 | Pass based on
- Single Sampling Plan, S-4,
AQL 4.0, - Multiple Sampling Plan, GII,
AQL 4.0 |
| 2. Length (mm) | | |
| Size | | |
| XS
S
M
L
XL | min 220
min 220
min 230
min 230
- | 245
255
297
249
253 |
| 3. Palm Width (mm) | | |
| Size | | |
| XS
S
M
L
XL | 70 ± 10
80 ± 10
95 ± 10
111 ± 10 - | 77
81
96
105
114 |
| 4. Single Wall Thickness
(mm) | | |
| Finger | min 0.08 | 0.36 |
| Palm | min 0.08 | 0.25 |
| TEST | ASTM
D3578-95 | DERMAGRIP Powder Free
Latex Examination Glove,
Non Sterile (Protein Content
Labeling) - refer to
Attachment 9 of Device Test
Report of Compliance |
| 5. Physical Properties | | |
| Before Aging : | | |
| Tensile Strength (MPa) | min 14 | 28.63 |
| Ultimate Elongation (%) | min 700 | 962 |
| After Aging : | | |
| Tensile Strength
(MPa) | min 14 | 18.43 |
| Ultimate Elongation
(%) | min 500 | 1007 |
| 6. Powder Content | - | below 2 mg/glove |
| 7. Protein Content | - | below 50 microgram/gram |
2
on based _ Assessment of Non-Clinical 8. Substantial Equivalence Performance Data
The performance test data of device as shown above indicate that this glove meets requirements of ASTM D 3578-95.
Protein content tested on recently manufactured and accelerated aging gloves using ASTM D5712 is below 50 microgram/gram.
9. Conclusion
のお洒落
This glove exceeds the ASTM D3578-95 requirements, meet FDA requirements for waterleak test on pinhole AQL and below 50 microgram/gram protein content labeling claim.
Date Summary Prepared : January 12, 1999.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 3 1999
Mr. Cheng Hean Khoo Senior Manager, Regulatory/Environmental Management WRP Specialty Products Sdn. Bhd. Lot 11, Janal 2, Kawasan Perusahaan Bander Baru Salak Tingqi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA
Re : K991044 Dermagrip Powder-Free Latex Examination Trade Name: Glove, Non-Sterile (Protein Content Labeling 50 micrograms or less) Requlatory Class: I Product Code: LYY March 26, 1999 Dated: Received: March 30, 1999
Dear Mr. Cheng Hean 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ 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 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.
4
Page 2 - Mr. Cheng Hean Khoo
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,
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.
144104 510(k) Number (if known) : __
DERMAGRIP POWDER FREE LATEX EXAMINATION Device Name : STERILE (PROTEIN CONTENT NON GLOVE. LABELING) ( 50 micrograms or Less )
Indications For Use :
10:30:00
- 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
Chin S. Kim
ivision of Dental, Infection Control. ad Genera! Hospital Devic 510(k) Number