(69 days)
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Not Found
No
The 510(k) summary describes a standard surgical glove and makes no mention of AI or ML technology.
No.
The primary purpose of the surgeon's glove is to prevent contamination, acting as a barrier for protection rather than directly treating or diagnosing a medical condition.
No
Explanation: The device is a surgeon's glove, intended to prevent contamination and protect wounds. It does not perform any diagnostic function.
No
The device is a physical glove made of natural rubber latex, not software. The description focuses on material properties and performance tests related to a physical product.
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/their environment. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description focuses on the physical properties and standards met by the glove (ASTM D3577-99), which are relevant to its barrier function and material, not to any diagnostic test.
- Performance Studies and Key Metrics: The performance studies and key metrics listed (watertightness, dimensions, physical properties) are all related to the glove's integrity and physical characteristics as a barrier, not to the accuracy or performance of a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. 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, 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 surgeons and/or 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's glove, 79 KGO, powder free, protein content labeling. It meets all of the requirements of ASTM standard D3577-99.
Mentions image processing
Not Found
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 3577-99 and FDA 1000 ml watertight test.
Key Results:
- Watertight (1000 ml): Pass based on 1) Single Sampling Plan, GI, AQL 1.5, 2) Multiple Sampling Plan, GII, AQL 2.5
- Length (mm):
- Size 5½: 294 (min 245)
- Size 6: 300 (min 265)
- Size 6½: 298 (min 265)
- Size 7: 309 (min 265)
- Size 7½: 291 (min 265)
- Size 8: 308 (min 265)
- Size 8½: 304 (min 265)
- Size 9: 301 (min 265)
- Palm Width (mm):
- Size 5½: 72 (70 ± 6)
- Size 6: 77 (76 ± 6)
- Size 6½: 83 (83 ± 6)
- Size 7: 90 (89 ± 6)
- Size 7½: 98 (95 ± 6)
- Size 8: 102 (102 ± 6)
- Size 8½: 108 (108 ± 6)
- Size 9: 114 (114 ± 6)
- Single Wall Thickness (mm):
- Finger: 0.27 (min 0.10)
- Palm: 0.24 (min 0.10)
- Cuff: 0.20 (min 0.10)
- Physical Properties:
- Before Aging:
- Tensile Strength (MPa): 29.58 (min 24)
- Ultimate Elongation (%): 902 (min 750)
- Stress at 500% Elongation (MPa): 2.95 (max 5.5)
- After Aging:
- Tensile Strength (MPa): 22.92 (min 18)
- Ultimate Elongation (%): 902 (min 560)
- Before Aging:
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).
Not Found
§ 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/Picture/0 description: The image shows a partial view of a logo or graphic, with the letters "WDR" prominently displayed in a bold, sans-serif font. Above and to the right of the letters, there is a circular shape with some markings inside, possibly representing a stylized design element. The overall composition is simple and graphic, with a focus on the letters "WDR" as the main visual element.
DEC - 2 1999
WRP Specialty Products Sdn Bhd
ATTACHMENT 3
1 1 2 7 1 3 V
Lot 11, Jalan 2, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA
TEL +60-3-846 2055 FAX +60-3-846 1437 URL www.wroworld.com
CONTACT PERSON : S.K.OOI
510(k) SUMMARY
-
- Trade Name : DERMAGRIP POWDER FREE LATEX SURGICAL GLOVE, STERILE (PROTEIN CONTENT LABELING) ( D micro pams or less )
-
- Common Name Surgeon's Gloves :
-
- Classification Name : Surgeon's Glove
4. Substantial Equivalence :
Class I natural rubber latex surgeon's glove, 79 KGO, powder free, protein content labeling. It meets all of the requirements of ASTM standard D3577-99.
5. Description of Device :
Class I natural rubber latex surgeon's glove, 79 KGO, powder free, protein content labeling. It meets all of the requirements of ASTM standard D3577-99.
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.
1
Image /page/1/Picture/0 description: The image contains the logo for WRP Specialty Products Sdn Bhd. The logo consists of the letters "WRP" in a bold, black font, set against a black oval shape. To the right of the logo is the text "WRP Specialty Products Sdn Bhd" in a simple, sans-serif font. There is also a handwritten number "5" in a circle above the logo.
7. Summary of Performance Data :
Performance data of gloves to ASTM D 3577-99 and FDA 1000 ml watertight test.
1 1 2 7 1 3 V
| TEST | ASTM D 3577-99 | DERMAGRIP Powder Free
Latex Surgical Glove, Sterile
(Protein Content Labeling) - refer
to Attachment 7 of Device Test
Report of Compliance |
|------------------------------------|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Watertight (1000 ml) | GI, AQL 1.5 | Pass based on
- Single Sampling Plan, GI,
AQL 1.5, - Multiple Sampling Plan, GII,
AQL 2.5 |
| 2. Length (mm)
Size | | |
| 5½ | min 245 | 294 |
| 6 | min 265 | 300 |
| 6½ | min 265 | 298 |
| 7 | min 265 | 309 |
| 7½ | min 265 | 291 |
| 8 | min 265 | 308 |
| 8½ | min 265 | 304 |
| 9 | min 265 | 301 |
| 3. Palm Width (mm)
Size | | |
| 5½ | $70 \pm 6$ | 72 |
| 6 | $76 \pm 6$ | 77 |
| 6½ | $83 \pm 6$ | 83 |
| 7 | $89 \pm 6$ | 90 |
| 7½ | $95 \pm 6$ | 98 |
| 8 | $102 \pm 6$ | 102 |
| 8½ | $108 \pm 6$ | 108 |
| 9 | $114 \pm 6$ | 114 |
| 4. Single Wall Thickness
(mm) | | |
| Finger | min 0.10 | 0.27 |
| Palm | min 0.10 | 0.24 |
| Cuff | min 0.10 | 0.20 |
| TEST | ASTM D 3577-99 | DERMAGRIP Powder Free
Latex Surgical Glove, Sterile
(Protein Content Labeling) - refer
to Attachment 7 of Device Test
Report of Compliance |
| 5. Physical Properties | | |
| Before Aging : | | |
| Tensile Strength (MPa) | min 24 | 29.58 |
| Ultimate Elongation (%) | min 750 | 902 |
| Stress at 500% Elongation
(MPa) | max 5.5 | 2.95 |
| After Aging : | | |
| Tensile Strength (MPa) | min 18 | 22.92 |
| Ultimate Elongation (%) | min 560 | 902 |
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 oval shape. To the right of the logo is the company name, "WRP Specialty Products Sdn Bhd" in a smaller, sans-serif font. Below the company name is the number "1 1 2 7 · 3 V".
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 3577-99.
9. Conclusion
This glove exceeds the ASTM D 3577-99 requirements, and also meet FDA requirements for water leak test on pinhole AQL.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 2 1999
Mr. Soo Kang Ooi Manager, Regulatory Affairs/Quality Assurance WRP Specialty Products Sdn. Bhd. Lot 11, Jalan 2, Kawasan Perusahaan Bandar Baru Salak Tinggi 43900 Sepang Selangor Darul Ehsan, Malaysia
K993214 Re : Dermagrip Powder-Free Latex Surgical Glove, Trade Name: Sterile (Protein Content Labeling 50 micrograms or less) Regulatory Class: I Product Code: KGO Dated: September 15, 1999 September 24, 1999 Received:
Dear Mr. Ooi:
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 Requlations, Title 21, Parts 800 to 895. ರ್ 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 Druq 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. Ooi
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 findinq of substantial equivalence of your device to a leqally 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) 594-4692. 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,
Patrícia Cincinato / for
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.
510(k) Number (if known)
DERMAGRIP POWDER FREE LATEX SURGICAL Device Name : GLOVE, STERILE (PROTEIN CONTENT LABELING) (50 micrograms on less)
Indications for Use :
- The surgeon's glove is a device made of natural rubber intended to be worn by 1. surgeons and/or operating room personnel to protect a surgical wound from contamination.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use OR
Dina S. Lin
Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number .