(69 days)
Not Found
K 993215
No
The 510(k) summary describes a standard surgeon's glove and its physical properties and testing, with no mention of AI or ML.
No.
A surgical glove is intended to protect from contamination, not to treat or directly restore health.
No
This device is a surgeon's glove, which is a protective barrier used during surgery to prevent contamination. Its function is not to diagnose medical conditions or diseases.
No
The device description clearly states it is a physical surgeon's glove made of natural rubber latex, which is a hardware component.
Based on the provided information, 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 surgeons and operating room personnel. This is a physical barrier function, not a diagnostic test performed on samples taken from the human body.
- Device Description: The device is a surgeon's glove, which is a physical barrier.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The information provided focuses on the physical properties and quality control of the glove as a barrier device.
N/A
Intended Use / Indications for Use
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 II natural rubber latex surgeon's glove, 79 KGO, powdered with absorbable dusting powder. It meets all of the requirements of ASTM standard D3577-99.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons and/or operating room 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)
The tensile physical properties are determined as described in ASTM D412 using Type C dumb bell test pieces. Test pieces are evaluated to conform to physical requirement on before and after accelerated aging. The accelerated aging is conducted by subjecting the test piece to a temperature of 100 ℃ ± 2 ℃ for 22 ± 0.3 hours.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
| Before Aging | After Aging | |
|---|---|---|
| Tensile Strength | Min 24 Mpa | Min 18 MPa |
| Ultimate Elongation | Min 750 % | Min 560 % |
| Stress at 500% Elongation | Max 5.5 Mpa | Not Applicable |
| Batch Size | : 300 000 pairs (based on one consignment quantity) |
|---|---|
| Sample Size | : 13 pcs |
| AQL | : 4.0 |
| Accept | : 1 pc |
| Reject | : 2 pcs |
Average Powder Weights on Size 7 ½ Surgical Gloves
| SIZE 7½ ACTUAL | POWDER WEIGHT* | |
|---|---|---|
| (%) | mg/glove | |
| Internal : 0.5 -1.5% | 1.41 | 204.7 |
| External (Max) : 1.0% | 0.96 | 140.0 |
- Average over eight (8) pieces.
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.
K 993215
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
DFC - 2 1999
Image /page/0/Picture/4 description: The image shows the logo for WRP. The logo consists of the letters "WRP" in a bold, sans-serif font, with the letters in white and set against a black, rounded rectangle. To the right of the logo is the text "WRP Spec" in a similar font, but without the black background. The text is also in black.
0
WRP Specialty Products Sdn Bhd
になると、とて
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.wrpwarld.com
ATTACHMENT 3
K 9932215
CONTACT PERSON : S.K.OOI
510(k) SUMMARY
- DERMAGRIP POWDERED LATEX SURGICAL 1. Trade Name : GLOVE, STERILE
- Surgeon's Gloves Common Name 2. :
- Classification Name Surgeon's Glove 3. :
4. Substantial Equivalence :
Class II natural rubber latex surgeon's glove, 79 KGO, powdered with absorbable dusting powder. It meets all of the requirements of ASTM standard D3577-99.
5. Description of Device :
Class II natural rubber latex surgeon's glove, 79 KGO, powdered with absorbable dusting powder. It meets all of the requirements of ASTM standard D3577-99.
6. Intended Use of Device :
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.
Gloves For All Reasons™
mber of the WRP Group of Companies
1
SUMMARIZED PROCEDURE OF THE QUALITY ASSURANCE METHODS 2. FOR SURGICAL GLOVES
-
(2) REFERENCE 2.1
K 993215 -
a) ASTM D 3577-99 Standard Specification for Rubber SURGICAL Gloves.
-
b) ASTM D 412-87 Standard Test Methods for Rubber Properties in Tension.
-
Sampling Procedures and Tables for Inspection by c) ISO 2859 Attributes.
-
d) ANSI/ASQC Z1.4-1993 Sampling Procedures and Tables for Inspection by Attributes.
2.2 SAMPLING
The gloves are sampled at random from a batch, where every part has an equal chance of being selected. The samples are selected and inspected in accordance with ISO 2859/ ANSI/ASQC Z1.4.
TEST METHODS 2.3
2.3.1 Physical Requirement Test
- a) The tensile physical properties are determined as described in ASTM D412 using Type C dumb bell test pieces. Test pieces are evaluated to conform to physical requirement on before and after accelerated aging.
- b) The accelerated aging is conducted by subjecting the test piece to a temperature of 100 ℃ ± 2 ℃ for 22 ± 0.3 hours.
c) Quality Requirement
| Before Aging | After Aging | |
|---|---|---|
| Tensile Strength | Min 24 Mpa | Min 18 MPa |
| Ultimate | ||
| Elongation | Min 750 % | Min 560 % |
| Stress at 500% | ||
| Elongation | Max 5.5 Mpa | Not Applicable |
- d) The inspection level : ANSI/ASQC Z1.4, (S-2)
| Batch Size | : 300 000 pairs (based on one consignment quantity) |
|---|---|
| Sample Size | : 13 pcs |
| AQL | : 4.0 |
| Accept | : 1 pc |
| Reject | : 2 pcs |
2
ুমি
Finished Powdered Gloves :
િ
Average Powder Weights on Size 7 ½ Surgical Gloves
| WRP Specialty Products Sdn.
| Bhd. | SIZE 7½ ACTUAL | POWDER WEIGHT* |
|---|---|---|
| (%) | mg/glove | |
| Internal : 0.5 -1.5% | 1.41 | 204.7 |
| External (Max) : 1.0% | 0.96 | 140.0 |
Average over eight (8) pieces.
ATTACHMENTS
| Number | Attached? | Subject |
|---|---|---|
| 1. | (/) Yes () No | Truthful & Accurate Statement |
| 2. | (/) Yes () No | Indications for Use Statement |
| 3. | (/) Yes () No | 510(k) Summary |
| 4. | (/) Yes () No | Summary of Quality Assurance Testing |
| Procedure of Dermagrip Powdered Latex | ||
| Surgical Glove, Sterile | ||
| 5. | (/) Yes () No | Label, Labeling and Advertising |
| 6. | (/) Yes () No | Biocompability Test Reports |
| 7. | (/) Yes () No | Device Test Report of Compliance of |
| Dermagrip Powdered Latex Surgical Glove, | ||
| Sterile according to ASTM D3577-99 and FDA | ||
| watertight test requirements. | ||
| 8. | (/) Yes () No | Validation on Gamma Radiation Sterilization |
| Cycle. | ||
| 9. | (/) Yes () No | Packaging Use to Maintain the Sterility of the |
| Gloves. | ||
| 10. | (/) Yes () No | Absorbable Dusting Powder Specification. |
| 11. | (/) Yes () No | Summary of Glove Physical Properties (refer to |
| Attachment 7, Device Test Report of | ||
| Compliance). | ||
| 12. | () Yes (/) No | Non-USP Powder Information |
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human profile with three overlapping faces, suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the image, emphasizing the organization's name and national affiliation. The overall design is simple and professional, conveying a sense of authority and public service.
Public Health Service
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
Re : K993215 Powdered Latex Surgical Glove, Sterile Trade Name: Regulatory Class: I Product Code: KGO September 15, 1999 Dated: Received: September 24, 1999
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, qood 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. ਉ 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 requlation may result in regulatory 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 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,
Patricia Cucurella /loc
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 POWDERED LATEX SURGICAL GLOVE, Device Name : STERILE
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
Olin S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number J