(102 days)
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No
The device is a standard surgeon's glove and the summary contains no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML development.
No
The device, a surgeon's glove, is intended to protect a surgical wound from contamination, not to treat or cure a disease or condition.
No
The device is a surgeon's glove, intended to protect from contamination, not to diagnose a condition.
No
The device description clearly states it is a "natural rubber latex surgeon glove," which is a physical hardware device. There is no mention of software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect a surgical wound from contamination by being worn by operating room personnel. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical properties and standards met by the glove (natural rubber latex, ASTM standards, watertight test, protein content). These are characteristics of a medical device used for protection, not for diagnosis.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis or monitoring of a disease or condition.
- Performance Studies and Metrics: The performance studies and metrics listed (watertightness, dimensions, tensile strength, elongation, powder/protein content) are all related to the physical integrity and safety of the glove as a barrier, not its ability to perform a diagnostic test.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This surgeon's glove does not fit that definition.
N/A
Intended Use / Indications for Use
The gloves are intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.
The surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Product codes (comma separated list FDA assigned to the subject device)
KGO
Device Description
Class I natural rubber latex surgeon glove, 79 KGO, powder free, protein content labeling, that meets all of the requirements of ASTM standard D3577-91.
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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare personnel, operating room 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 3577-91 and FDA 1000 ml watertight test.
TEST: 1. Watertight (1000 ml)
ASTM D 3577-91: S-4,AQL 1.5
PROFEEL Powder Free Surgical Gloves (Protein Content Labeling): Pass based on AQL of 1.0
TEST: 2. Length (mm)
Size 5½: ASTM D 3577-91 min 245, PROFEEL Powder Free Surgical Gloves (Protein Content Labeling) 277
Size 6: ASTM D 3577-91 min 265, PROFEEL Powder Free Surgical Gloves (Protein Content Labeling) 282
Size 6½: ASTM D 3577-91 min 265, PROFEEL Powder Free Surgical Gloves (Protein Content Labeling) 281
Size 7: ASTM D 3577-91 min 265, PROFEEL Powder Free Surgical Gloves (Protein Content Labeling) 299
Size 7½: ASTM D 3577-91 min 265, PROFEEL Powder Free Surgical Gloves (Protein Content Labeling) 298
Size 8: ASTM D 3577-91 min 265, PROFEEL Powder Free Surgical Gloves (Protein Content Labeling) 298
Size 8½: ASTM D 3577-91 min 265, PROFEEL Powder Free Surgical Gloves (Protein Content Labeling) 298
Size 9: ASTM D 3577-91 min 265, PROFEEL Powder Free Surgical Gloves (Protein Content Labeling) 299
TEST: 3. Palm width (mm)
Size 5½: ASTM D 3577-91 70 ± 6, PROFEEL Powder Free Surgical Gloves (Protein Content Labeling) 72
Size 6: ASTM D 3577-91 76 ± 6, PROFEEL Powder Free Surgical Gloves (Protein Content Labeling) 78
Size 6½: ASTM D 3577-91 83 ± 6, PROFEEL Powder Free Surgical Gloves (Protein Content Labeling) 83
Size 7: ASTM D 3577-91 89 ± 6, PROFEEL Powder Free Surgical Gloves (Protein Content Labeling) 90
Size 7½: ASTM D 3577-91 95 ± 6, PROFEEL Powder Free Surgical Gloves (Protein Content Labeling) 95
Size 8: ASTM D 3577-91 102 ± 6, PROFEEL Powder Free Surgical Gloves (Protein Content Labeling) 102
Size 8½: ASTM D 3577-91 108 ± 6, PROFEEL Powder Free Surgical Gloves (Protein Content Labeling) 108
Size 9: ASTM D 3577-91 114 ± 6, PROFEEL Powder Free Surgical Gloves (Protein Content Labeling) 114
TEST: 4. Thickness (mm)
Finger: ASTM D 3577-91 min 0.10, PROFEEL Powder Free Surgical Gloves (Protein Content Labeling) 0.23
Palm: ASTM D 3577-91 min 0.10, PROFEEL Powder Free Surgical Gloves (Protein Content Labeling) 0.20
TEST: 5. Physical Properties
Before Aging:
Tensile Strength (MPa): ASTM D 3577-91 min 24, PROFEEL Powder Free Surgical Gloves (Protein Content Labeling) 28.19
Ultimate Elongation (%): ASTM D 3577-91 min 750, PROFEEL Powder Free Surgical Gloves (Protein Content Labeling) 827
After Aging:
Tensile Strength (MPa): ASTM D 3577-91 min 18, PROFEEL Powder Free Surgical Gloves (Protein Content Labeling) 22.23
Ultimate Elongation (%): ASTM D 3577-91 min 560, PROFEEL Powder Free Surgical Gloves (Protein Content Labeling) 898
TEST: 6. Powder Content
PROFEEL Powder Free Surgical Gloves (Protein Content Labeling): below 2 mg / glove
TEST: 7. Protein Content
PROFEEL Powder Free Surgical Gloves (Protein Content Labeling): below 50 microgram / gram
Key Results: This glove exceed the ASTM D 3577-91 requirements, meet pinhole FDA requirements and below 50 microgram / gram protein content labeling claim.
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.
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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.
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).
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§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).
0
Image /page/0/Figure/0 description: The image shows the letters "WRP" in a bold, sans-serif font. The letters are arranged horizontally, with "W" on the left, "R" in the middle, and "P" on the right. The letters are black and are surrounded by a thick black border that forms a rounded rectangle. The background of the image is white.
5972621
WEMBLEY RUBBER PRODUCTS (M) S
' ot 1, Jalan 3, Kawasan Perusahaan Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehean, Malaysia nt 1, Jalan 3, Kawasan Petusanaan Baliuar Baru Baru Sarak Tinggi, 1990- Bopang, 1996-1495 / 1496 Fax: (603) 846-1488 / 1608
OCT 2 4 1997
CONTACT PERSON : MR. Y. W. CHOW
510 (K) SUMMARY
- : PROFEEL POWDER FREE SURGICAL GLOVES 1. Trade Name (PROTEIN CONTENT LABELING) ( 50 MKroqram or
-
- Common Name : Surgeon Gloves .
-
- Classification Name : Surgeon Glove
4. Substantial Equivalence :
Class I natural rubber latex surgeon glove, 79 KGO, powder free, protein content labeling, that meets all of the requirements of ASTM standard D3577-91.
5. Description of device :
Class I natural rubber latex surgeon glove, 79 KGO, powder free, protein content labeling, that meets all of the requirements of ASTM standard D3577-91.
6. Intended use of device :
The gloves are intended to be worn on the hand of healthcare personnel, operating room 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
Image /page/0/Picture/17 description: The image shows a circular logo with the letter 'A' in the center. The words 'REGISTERED MANUFACTURER' are written around the top half of the circle, and 'DM' is written at the bottom. The logo appears to be a stamp or seal, possibly indicating that a product or company is registered as a manufacturer.
Image /page/0/Picture/18 description: The image shows a circular logo with a heart and an inverted triangle inside. The logo is surrounded by text, but the text is not clear enough to read. The logo appears to be a certification mark or a symbol of quality assurance. The image is black and white and has a slightly grainy texture.
Image /page/0/Picture/19 description: The image shows a black and white logo. The logo consists of a black diamond shape with a white border. Above the diamond is a white oval shape with the word "REGISTERED" in black letters. Below the diamond are the letters "MS ISO 9002 : 1994".
Image /page/0/Picture/20 description: The image shows the CE marking, a symbol used to indicate conformity with health, safety, and environmental protection standards for products sold within the European Economic Area. The letters 'CE' are prominently displayed, and below the marking, the text 'COUNCIL DIRECTIVE 93/42/EEC' is visible. This directive is related to medical devices, suggesting the product bearing this mark complies with the relevant European regulations for medical devices.
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7. Summary of Performance data :
K972621
Performance data of gloves to ASTM D 3577-91 and FDA 1000 ml watertight test.
| TEST | ASTM D 3577-91 | PROFEEL Powder Free
Surgical Gloves (Protein
Content Labeling) |
|-------------------------|----------------|----------------------------------------------------------------------|
| 1. Watertight (1000 ml) | S-4,AQL 1.5 | Pass based on AQL of 1.0 |
| 2. Length (mm) | | |
| Size | | |
| 5½ | min 245 | 277 |
| 6 | min 265 | 282 |
| 6½ | min 265 | 281 |
| 7 | min 265 | 299 |
| 7½ | min 265 | 298 |
| 8 | min 265 | 298 |
| 8½ | min 265 | 298 |
| 9 | min 265 | 299 |
| 3. Palm width (mm) | | |
| Size | | |
| 5½ | 70 ± 6 | 72 |
| 6 | 76 ± 6 | 78 |
| 6½ | 83 ± 6 | 83 |
| 7 | 89 ± 6 | 90 |
| 7½ | 95 ± 6 | 95 |
| 8 | 102 ± 6 | 102 |
| 8½ | 108 ± 6 | 108 |
| 9 | 114 ± 6 | 114 |
| 4. Thickness (mm) | | |
| Finger | min 0.10 | 0.23 |
| Palm | min 0.10 | 0.20 |
| 5. Physical Properties | | |
| Before Aging : | | |
| Tensile Strength (MPa) | min 24 | 28.19 |
| Ultimate Elongation (%) | min 750 | 827 |
| After Aging : | | |
| Tensile Strength (MPa) | min 18 | 22.23 |
| Ultimate Elongation (%) | min 560 | 898 |
| 6. Powder Content | - | below 2 mg / glove |
| 7. Protein Content | - | below 50 microgram / gram |
Page 2 Of 3
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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 3577-91.
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 3577-91 requirements, meet pinhole FDA requirements and below 50 microgram / gram protein content labeling claim.
Date Summary Prepared : June 14, 1997
Page 3 of 3
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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 stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Yue Wah Chow Vice President, Quality Assurance/Regulatory Affairs Wembley Rubber Products (M) Sdn. Bhd. OCT 2 4 1997 Lot 1, Jalan 3 Kawasan Perusahaan Bandar Baru Salak Tinggi, Sepang Selangor, Malaysia
Re : K972621 Profeel Powder Free Latex Surgical Gloves Trade Name: (Protein Content Labeling Claim (50 Microgram or Less) Regulatory Class: I Product Code: KGO Dated: October 14, 1997 October 14, 1997 Received:
Dear Mr. Chow:
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 aqainst 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
4
Page 2 - Mr. Chow
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 requlations.
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) 594-4618. 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
: .
510(k) Number (if known) : _ K 9 7 26 2 |
Device Name : PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING) 50 Microgram of Less
】
【
Indications For Use :
-
- The surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Concurrence of CDRH, Office of Device Evaluation (ODE)
- The surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
| S. Lim | |
|---|---|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K972621 |
| Prescription Use (Per 21 CFR 801.109) | OR Over-The-Counter Use X |
|---|---|
| --------------------------------------- | --------------------------- |