(83 days)
The surgical glove is a device made of natural rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.
The device in this 510(k) submission is the Powdered Latex Surgical Gloves. Sterile which is made of natural rubber latex.
The provided text describes a 510(k) submission for "Powdered Latex Surgical Gloves, Sterile" and explicitly states that the only difference from the predicate device (Comfit Beaded Surgeon's Gloves, Powdered and Hypoallergenic, K951662) is the inclusion of an Expiration Date Labeling Claim. The submission focuses on demonstrating that the device maintains its properties over the claimed shelf-life.
Therefore, the acceptance criteria and study detailed are specifically about shelf-life stability, not a clinical performance study of the gloves in a medical context.
Here's the breakdown of the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measured Parameters for Stability) | Reported Device Performance (Maintained for 5 years) |
|---|---|
| Barrier properties | Maintained |
| Physical properties | Maintained |
| Mechanical properties | Maintained |
| Packaging integrity | Maintained |
| Sterility | Maintained |
2. Sample Size Used for the Test Set and Data Provenance
The text mentions "results of stability study conducted on Powdered Latex Surgical Gloves, Sterile" but does not specify:
- The sample size used for the stability study (test set).
- The data provenance (e.g., country of origin, retrospective or prospective). However, it's inherently a prospective study by nature (stability studies track products over time).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable to a shelf-life stability study. Ground truth in this context is established by laboratory testing against predefined specifications, not expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
Not applicable. The "test set" here refers to samples from the stability study, and their performance is measured objectively rather than through adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is for comparing human performance (with or without AI assistance) in tasks like image interpretation, which is not relevant to the shelf-life stability of surgical gloves.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical product (surgical gloves), not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth for the stability study is established by objective laboratory measurements and tests against established specifications for:
- Barrier properties (e.g., integrity, leak tests)
- Physical properties (e.g., dimensions, visual inspection)
- Mechanical properties (e.g., tensile strength, elongation, force at break)
- Packaging integrity (e.g., seal strength)
- Sterility (e.g., microbiological testing)
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as point 8.
{0}------------------------------------------------
3 2002 JUL
Image /page/0/Picture/1 description: The image shows a logo with the letters "WRP" in white against a black background. The letters are bold and sans-serif. The background is a hexagon shape with rounded corners. The logo has a slightly distressed or textured appearance.
T
T
T
WRP Asia Pacific Sdn Bhd
KO2115)
510 (K) SUMMARY OF POWDERED LATEX SURGICAL GLOVES, STERILE
The device in this 510(k) submission is the Powdered Latex Surgical Gloves. Sterile which is made of natural rubber latex. These gloves are intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.
The Powdered Latex Surgical Gloves, Sterile are substantially equivalent to Comfit Beaded Surgeon's Gloves, Powdered and Hypoallergenic submitted and cleared under 510(k) number K951662. The only difference in this submission is to include the Expiration Date Labeling Claim with no changes in manufacturing process and product design. The results of stability study conducted on Powdered Latex Surgical Gloves, Sterile are submitted to support the expiration date labeling.
Based on the results obtained through out the Stability Test, it can be concluded that the Powdered Latex Surgical Gloves, Sterile produced by WRP Asia Pacific Sdn Bhd has demonstrated that the barrier properties, physical and mechanical properties, packaging integrity and sterility of the gloves are maintained for the duration of the claimed shelf-life (expiration date, i.e. 5 years).
TM
Page 1 of 1
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
3 2002 របប
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. K. K Leong Associate Manager, QA/RA Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang Selangor Darul Ehsan, MALAYSIA
Re: K021159
Trade/Device Name: Regulation Number: 878.4460 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: KGO Dated: April 9, 2002 Received: April 11, 2002
Dear Mr. Leong:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{2}------------------------------------------------
Page 2 - Mr. Leong
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours.
Susan Runner
-Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows a logo with the letters "WRP" in a bold, sans-serif font. The letters are white and are set against a black, rounded, polygon-shaped background. The logo appears to be a stylized representation of the company's initials. The image is clear and well-defined, with a high contrast between the white letters and the black background.
INDICATIONS FOR USE
Applicant:
510(k) Number (if known):
ber (if known):
Device Name:
WRP Asia Pacific Sdn Bhd
KO21159
POWDERED LATEX SURGICAL GLOVES, WITH STERILE EXPIRATION DATE LABELING CLAIM
Indications For Use:
The surgical glove is a device made of natural rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qiis S. Lin
(Division Sign-Off) (Division Sign-Off)
Division of Dental, Infection Control, Division of Devices Division of Deliver and General Devices NO 510(k) Number -
OR
TM
Prescription Use (Per 21 CFR 801.109)
T
די
てて
n
Over-The-Counter
Page 1 of 1
§ 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).