(562 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of a medical glove, with no mention of AI or ML technologies.
No.
The device is a glove for preventing contamination, not for treating a disease or condition.
No
The device is a medical glove intended to prevent contamination, not to diagnose a medical condition.
No
The device description clearly states it is a "Class I latex patient examination glove," which is a physical hardware device. The performance studies and key metrics also relate to the physical properties of the glove (watertightness, dimensions, tensile strength, etc.). There is no mention of software as a component or the primary function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between the examiner and chemotherapy agents by being worn on the hand or finger. This is a barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: It's described as a "specialty medical glove," specifically a "latex patient examination glove." Gloves are generally considered medical devices, but not IVDs.
- Lack of Diagnostic Function: There is no mention of analyzing a sample (blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition.
- Performance Data: The performance data focuses on the physical properties of the glove (watertightness, dimensions, tensile strength, protein content, etc.), which are relevant to its barrier function, not a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This glove does not perform any such function.
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 chemotherapy agents and also can be used to prevent contamination between the healthcare or similar personnel and the patient's body , fluids, waste , or environment.
- The chemotherapy examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and chemotherapy agents.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
Class I latex patient examination glove 80 LZC, powder free, protein content labeling, that meets all of the requirements of ASTM standard D3578-91.
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 3578-91 and FDA 1000 ml watertight test.
Key results include:
- Watertight (1000 ml): Pass based on AQL of 1.5 (ASTM D 3578-91: S-4, AQL 4.0)
- Length (mm): S: 295, M: 293, L: 298 (ASTM D 3578-91: min 230)
- Palm width (mm): S: 83, M: 94, L: 106 (ASTM D 3578-91: S: 80 +/- 10, M: 95 +/- 10, L: 111 +/- 10)
- Thickness (mm): Finger: 0.27, Palm: 0.17 (ASTM D 3578-91: min 0.08)
- Physical Properties:
Before Ageing: Tensile Strength (MPa): 25.48 (ASTM D 3578-91: min 21); Ultimate Elongation (%): 856 (ASTM D 3578-91: min 700)
After Ageing: Tensile Strength (MPa): 20.81 (ASTM D 3578-91: min 16); Ultimate Elongation (%): 969 (ASTM D 3578-91: min 500) - Powder Content: below 2 mg / glove
- Moisture Content: max 0.8% / glove
- Protein Content: below 50 microgram / gram
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
JAN 27 1999
Image /page/0/Picture/1 description: The image shows a logo with the letters "WRP" in bold, black font. The letters are slightly distressed, giving them a textured appearance. The letters are enclosed within a rounded rectangular shape, also in black. The logo has a simple, clean design.
972616
WEMBLEY RUBBER PRODUCTS (M) SDN BHD (No: 147817-V)
l or 1, Jalan 3, Kawasan Perusahaan Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, Malaysia rketing / QA Tel: (603) 846-1486 / 1867 Fax: (603) 846-1485 / 1557 Operations Tel: (603) 846-1495 / 1496 Fax: (603) 846-1488 / 1608
CONTACT PERSON : MR. Y. W. CHOW
510 (K) SUMMARY
- : ONCOLOGY PLUS POWDER FREE LATEX 1. Trade Name EXAMINATION GLOVES (PROTEIN CONTENT LABEI ING)
-
- Common Name : Examination Gloves
-
- Classification Name : Patient Examination Glove
4. Substantial Equivalence :
Class I latex patient examination glove 80 LZC, powder free, protein content labeling, that meets all of the requirements of ASTM standard D3578-91.
5. Description of device :
Class I latex patient examination glove 80 LZC, powder free, protein content labeling, that meets all of the requirements of ASTM standard D3578-91.
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 chemotherapy agents and also can be used to prevent contamination between the healthcare or similar personnel and the patient's body , fluids, waste , or environment.
Page 1 of 3
Image /page/0/Picture/17 description: The image shows a circular logo with the letter 'A' in the center. The words 'REGISTERED MANUFACTURER' are arranged around the top half of the circle, and the letters 'OH' are at the bottom. The logo appears to be a stamp or seal, possibly indicating registration or certification of a manufacturer in Ohio.
Image /page/0/Picture/18 description: The image shows a circular logo with the words "REGISTERED FIRM" around the perimeter. Inside the circle is an inverted triangle shape. Above the triangle is a horizontal line with a small square on top of it.
Image /page/0/Picture/19 description: The image shows a black diamond shape with a white stripe across the top. The word "REGISTERED" is printed in black letters on the white stripe. The diamond shape is oriented with one point facing up and one point facing down.
Image /page/0/Picture/20 description: The image shows the CE marking, which consists of the letters 'C' and 'E'. The 'C' is a simple, curved shape, while the 'E' is also curved but with a shorter middle stroke. This marking indicates that a product conforms to health, safety, and environmental protection standards for products sold within the European Economic Area.
1
7. Summary of Performance data :
・・ Performance data of gloves to ASTM D 3578-91 and FDA 1000 ml watertight test.
| TEST | ASTM D 3578-91 | ONCOLOGY PLUS Powder
Free Latex Examination
Gloves (Protein Content
Labeling) |
|-------------------------|----------------|----------------------------------------------------------------------------------------|
| 1.Watertight (1000 ml) | S-4, AQL 4.0 | Pass based on AQL of 1.5 |
| 2. Length (mm) | | |
| Size XS | - | - |
| S | min 230 | 295 |
| M | min 230 | 293 |
| L | min 230 | 298 |
| XL | - | - |
| 3. Palm width (mm) | | |
| Size XS | - | - |
| S | $80 \pm 10$ | 83 |
| M | $95 \pm 10$ | 94 |
| L | $111 \pm 10$ | 106 |
| XL | - | - |
| 4. Thickness (mm) | | |
| Finger | min 0.08 | 0.27 |
| Palm | min 0.08 | 0.17 |
| 5. Physical Properties | | |
| Before Ageing : | | |
| Tensile Strength (MPa) | min 21 | 25.48 |
| Ultimate Elongation (%) | min 700 | 856 |
| After Ageing : | | |
| | | |
| Tensile Strength (MPa) | min 16 | 20.81 |
| Ultimate Elongation (%) | min 500 | 969 |
| 6.Powder Content | - | below 2 mg / glove |
| 7. Moisture Content | - | max 0.8% / glove |
| 8. Protein Content | - | below 50 microgram / gram |
2
8. Substantial Equivalence based on assessment of Non-Clinical performance data
The performance test data of device as shown above indicate that this glove meets requirements of ASTM D 3578-91.
Protein content tested on recently manufactured and accelerated ageing gloves using ASTM D5712 is below 50 microgram / gram.
9. Conclusion
This glove exceed the ASTM D 3578-91 requirements, meet pinhole FDA requirements, and below 50 microgram / gram protein content labeling claim.
Date Summary Prepared : June 16, 1997
Page 3 of 3
3
DEPARTMENT OF HEALTH & HUMAN SERVICES • USA
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 27 1999
Mr. Chow Yue Wah Vice President QA/RA Wembley Rubber Products (M) Sdn. Bhd. Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA
K972616 Re : Oncology Plus Powder-Free Latex Examination Trade Name: Gloves (Protein Content Labeling, (50 Micrograms or Less) Regulatory Class: I Product Code: LYY Dated: November 10, 1998 Received: November 17, 1998
Dear Mr. Chow Yue Wah:
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 legally marketed predicate 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. 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
4
Page 2 - Mr. Chow Yue Wah
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" (21CFR 807.97). Other qeneral 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/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Directpr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known) : __K972614
Device Name : ONCOLOGY PLUS POWDER FREE LATEX EAMINATION GLOVES (PROTF N CONTENT LABELING) 50) IQ ICECC20105 ON LESS
Indications For Use :
-
- The chemotherapy examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and chemotherapy agents.
Concurrence of CDRH, Office of Device Evaluation (ODE)
- The chemotherapy examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and chemotherapy agents.
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use OR
Clim S. lin
(Division Sign-Off) Division of Dental. Infection Control, and General Hospital Devices 510(k) Number