(126 days)
A powder free polymer coated latex surgical glove is a disposable device made of natural rubber material intended to be worn by operating room personnel to protect a surgical wound from contamination.
The Powder Free Polymer Coated Latex Surgical Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein will meet all the current specification for ASTM D3577.
Here's a breakdown of the acceptance criteria and study information for the "Powder Free Polymer Coated Latex Surgical Gloves" based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D3577 - 06 | Meets |
| ASTM D 412 - 06ael | Meets | |
| Freedom from pin-holes | ASTM D 5151 - 06 | Meets |
| Powder Free Residue | ASTM D 6124 - 06 | Meets |
| Biocompatibility: Dermal Sensitization | Dermal Sensitization (as per ISO 10993-10) | Not a contact skin sensitizer |
| Biocompatibility: Primary Skin Irritation | Primary Skin Irritation Test (as per ISO 10993-10) | Not a primary skin irritant |
| Protein Labeling Claim | 50 micrograms per dm² of glove or less of water soluble protein | Meets (implied by overall conclusion of safety and effectiveness) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide specific details on the sample size used for the tests to demonstrate compliance with the ASTM and ISO standards. It states that "The performance test data that support a determination of substantial equivalence are described above," referring to the "Device Performance" column in the table.
Regarding data provenance, the document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The manufacturer is based in Malaysia.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable to this type of device and study. The testing for surgical gloves involves physical and chemical property assessments based on established international standards (ASTM, ISO), not expert interpretation of diagnostic images or patient outcomes.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation, such as in medical imaging, to resolve discrepancies among experts establishing ground truth. The tests for surgical gloves are objective measurements against defined standards.
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 relevant for evaluating the impact of an AI system on human reader performance, which is not applicable to a physical medical device like surgical gloves.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, a standalone study was done in the sense that the device's performance was evaluated independently against the specified standards without human intervention influencing the device itself. However, this is not an "algorithm-only" study as the device is a physical product, not a software algorithm. The "Device Performance" column reflects the standalone performance of the gloves.
7. The Type of Ground Truth Used:
The ground truth used for this device is based on established objective measurements and performance specifications defined by international standards (ASTM and ISO). For example:
- Dimensions: Measured directly and compared against ASTM D3577.
- Freedom from pin-holes: Evaluated according to ASTM D5151.
- Powder Free Residue: Measured according to ASTM D6124.
- Biocompatibility (Dermal Sensitization, Primary Skin Irritation): Assessed using standardized biological tests as per ISO 10993-10, with defined criteria for "not a contact skin sensitizer" and "not a primary skin irritant."
8. The Sample Size for the Training Set:
This information is not applicable. Surgical gloves are physical devices tested against predefined standards, not machine learning models that require training sets.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for this type of device.
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Wear Safe (Malaysia) Sdn.Bhd. (Company No.204396-X)
FDA 510(k), Premarket Notification : 510(k) Summary of Safety and Effectiveness Information
Submitter: 1.0
WEAR SAFE (MALAYSIA) SDN. BHD. Lot PT 13726, Jalan Haji Salleh, Off Jalan Meru, 41050 Klang, Selangor Darul Eshan, Malaysia.
+603 3392 3088 Telephone No .: 4603 3392 2118 Fax No .:
Contact Person: 2.0
| Contact: | Mr. SH TAN |
|---|---|
| E-mail: | shtan@kossan.com.my |
| Telephone No.: | +603 3291 2657 |
| Fax No.: | +603 3291 0584 |
3.0 Name of Device:
.
Powder Free Polymer Coated Latex Surgical Gloves, Sterile, with Trade Name: Protein Labeling claim of 50 micrograms per dm- of glove or less of water soluble protein. Surgeon's Glove Common Name: Classification Name: Surgeon's Glove
Identification of The Legally Marketed Device: 4.0
The Powder Free Polymer Coated Latex Surgical Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein, Class I surgeon's gloves, 79KGO, meets all of the requirements of ASTM D3577 Standard Specification for Rubber Surgical Gloves for Medical Application.
Description of Device: રું..........................................................................................................................................................................
The Powder Free Polymer Coated Latex Surgical Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein will meet all the current specification for ASTM D3577.
Lot 13726, Jalan Haji Salleh, Batu 5¼ Off Jalan Meru, 41050 Klang, Selangor Darul Ehsan Malaysia. Tel: 603-33923088, Fax: 603-33922599
MAY 15 2009
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Intended Use of the Device: 6.0
The Powder Free Polymer Coated Latex Surgical Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein is a disposable device intended for medical purposes that is intended to be worn by operating room personnel to protect a surgical wound from contamination.
Summary of The Technological Characteristics of The Device: 7.0
The Powder Free Polymer Coated Latex Surgical Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm3 of glove or less of water soluble protein possesses the following technological characteristic (as compared to ASTM or equivalent standards):
| Characteristic | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D3577 - 06 | Meets |
| ASTM D 412 - 06ael | Meets | |
| Freedom from pin-holes | ASTM D 5151 - 06 | Meets |
| Powder Free Residue | ASTM D 6124 - 06 | Meets |
| Biocompatibility | Dermal Sensitization(as per ISO 10993-10) | Not a contact skin sensitizer |
| Primary Skin Irritation Test(as per ISO 10993-10) | Not a primary skin irritant |
Substantial Equivalent Based on Assessment of Non-Clinical Performance Data 8.0
The performance test data that support a determination of substantial equivalence are described above.
Substantial Equivalent Based on Assessment of Clinical Performance Data 9.0
Clinical data are not needed for market cleared surgical gloves.
10.0 Conclusion
It can be concluded that the Powder Free Polymer Coated Latex Surgical Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein is safe and effective for use and will perform according to the glove performance standards referenced in Section 7 above, thereby meeting ASTM standards, FDA requirements, and the labeling claims for the product.
Consequently, this device is substantially equivalent to current marketed devices.
This summary will include any other information reasonably deemed necessary by the FDA.
Lot 13726, Jalan Haji Salleh, Batu 5¼ Off Jalan Meru, 41050 Klang, Selangor Darul Ehsan Malaysia. Tel: 603-33923088, Fax: 603-33922599
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem depicts a bird-like figure with three curved lines forming its body and tail, symbolizing health and human services.
Public Health Service
MAY 15 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. SH Tan Wear Safe (Malaysia) Sdn.Bhd. Lot 13726 Jalan Haji Salleh Batu 51/4 Off Jalan Meru 41050 Klang Selangor Darul Ehsan MALAYSIA
Re: K090066
Trade/Device Name: Powder Free Polymer Coated Latex Surgical Gloves, Sterile, With Protein Labeling Claim of 50 Micrograms Per DM2 Glove Or Less Of Water Soluble Protein.
Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: April 27, 2009 Received: April 30, 2009
Dear Mr. Tan:
We have reviewed vour 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 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.
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Page 2- Mr. Tan
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Tunner
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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WSM Wear Safe (Malaysia) Sdn.Bhd. (Company No.204396-X)
INDICATIONS FOR USE
Applicant:
WEAR SAFE (MALAYSIA) SDN. BHD.
510(k) Number (if known):
Device Name:
Powder Free Polymer Coated Latex Surgical Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm- of glove or less of water soluble protein.
Indication For Use:
A powder free polymer coated latex surgical glove is a disposable device made of natural rubber material intended to be worn by operating room personnel to protect a surgical wound from contamination.
Prescription Use -(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shulin M. Murphy
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090466
Page 1 of 1
Lot 13726, Jalan Haji Salleh, Batu 5¼ Off Jalan Meru, 41050 Klang, Selangor Darul Ehsan Malaysia. Tel: 603-33923088, Fax: 603-33922599
§ 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).