(114 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 Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile with Aloe Vera and with Protein Content Labeling Claim is equivalent to the existing model, i.e. Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) Contains 50 Micrograms or Less of Total Water Extractable Protein per gram which had submitted and cleared under 510(k) number K021784. The difference in this submission is: With Aloe Vera coated on surgical gloves.
The provided document describes a medical device, "Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim," and its equivalence to a predicate device. The information presented is for a 510(k) premarket notification and focuses on demonstrating that the modified device meets established standards.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Standards | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimensions | ASTM D 3577 - 06 | Meets ASTM D 3577 - 06 | Meets |
| Physical Properties | ASTM D 3577 - 06 | Meets ASTM D 3577 - 06 | Meets |
| Freedom from pinholes | ASTM D 3577 - 06 & FDA 21 CFR 800.20 | Meets ASTM D 3577 - 06 & FDA 21 CFR 800.20 | Meets |
| Powder Residual | ASTM D 6124 - 06 | < 2 mg/glove | < 2 mg/glove |
| Protein Level | ASTM D 5712-99 | < 50 µg/g | < 50 µg/g |
| Biocompatibility: Primary Skin Irritation | Primary Skin Irritation in Rabbits | Passes (Not a primary skin irritant) | Passes (Not a primary skin irritant) |
| Biocompatibility: Dermal Sensitization | Dermal Sensitization | Passes (Not a contact sensitizer) | Passes (Not a contact sensitizer) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for the tests performed to demonstrate compliance with the acceptance criteria. For instance, it doesn't specify how many gloves were tested for pinholes, dimensions, or physical properties. Similarly, the number of animals (rabbits) used for the biocompatibility tests is not mentioned.
The data provenance is from Malaysia, as stated in the submitter's address: "Lot 1, Jalan 3, Kawasan Perushaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA." The studies appear to be prospective as they were conducted to demonstrate that the modified device meets the specified standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The standards (ASTM, FDA regulations) inherently define the "ground truth" for the device's performance characteristics. The tests are designed to measure against these established standards. However, details about the personnel who conducted or validated these tests, or their qualifications, are not included.
4. Adjudication Method for the Test Set:
An adjudication method is not applicable in this context. The document describes standardized tests against predefined criteria (e.g., "Meets ASTM D 3577 - 06"). The results are objective measurements or pass/fail determinations based on these standards, not subjective interpretations requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human interpretation of images or data is involved, often with AI assistance. The device in question is a surgical glove, and its performance is evaluated through physical and chemical property tests, not human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone (algorithm only) performance study was not done. This concept is irrelevant for a surgical glove. The "device performance" refers to the glove's physical and chemical attributes, not an algorithm's output.
7. The Type of Ground Truth Used:
The ground truth used for this device is based on established industry standards and regulatory requirements. Specifically, these include:
- ASTM Standards: Such as ASTM D 3577 - 06 for dimensions, physical properties, and freedom from pinholes; ASTM D 6124 - 06 for powder residual; and ASTM D 5712-99 for protein level.
- FDA Regulations: Specifically 21 CFR 800.20 for freedom from pinholes.
- Biocompatibility Testing: "Primary Skin Irritation in Rabbits" and "Dermal Sensitization" are standard biological evaluation tests designed to determine if a material causes irritation or sensitization.
8. The Sample Size for the Training Set:
This concept is not applicable to this device. A "training set" refers to data used to train a machine learning algorithm. Surgical gloves are physical medical devices, and their performance is assessed through standardized physical and chemical tests, not AI models.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the same reasons as #8. No training set or machine learning algorithm is involved in the evaluation of this device.
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Image /page/0/Picture/0 description: The image shows a logo with the letters "VWRP" in a stylized font. The "V" is large and bold, with a design that suggests movement or flow. The letters "WRP" are smaller and placed to the right of the "V", creating a sense of balance in the logo. The logo is in black and white.
SPECIAL 510(k) SUMMARY
JUN 2 7 2007
1.0 Submitter:
| Name: | WRP Asia Pacific Sdn Bhd |
|---|---|
| Address: | Lot 1, Jalan 3, Kawasan Perushaan Bandar Baru Salak Tinggi,43900 Sepang, Selangor Darul Ehsan, MALAYSIA |
| Phone No.: | +60 3 8706 1486 |
| Fax No.: | +60 3 8706 1557 |
Date of Summary Prepared:
28 FEB 2007
2.0 Contact Person:
| Name: | Mr. Kirk Penner |
|---|---|
| Phone No.: | +60 3 8706 1486 Ext. 148 |
| Fax No.: | +60 3 8706 1557 |
3.0 Device Identification:
| Trade Name: | 1) Eudermic, and2) Multiple or Customers' Trade Name |
|---|---|
| Device Name: | Powder Free Polymer Coated Brown Latex Surgical Gloves,Sterile, Coated with Aloe Vera and with Protein ContentLabeling Claim (50 micrograms or less) |
| Common Name: | Surgical Gloves |
| Classification Name: | Surgeon's Gloves (per 21 CFR 878.4460) |
4.0 Identification of the Legally Marketed Device:
Class I Powder Free natural rubber latex surgeon's gloves, 79KGO, that meets all the requirements of ASTM standard D 3577 - 06 Type 1 and FDA 21 CFR 800.20.
5.0 Description of the Device:
The Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile with Aloe Vera and with Protein Content Labeling Claim is equivalent to the existing model, i.e. Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) Contains 50 Micrograms or Less of Total Water Extractable Protein per gram which had submitted and cleared under 510(k) number K021784.
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Image /page/1/Picture/0 description: The image shows a logo with the letters "WRP" in bold, black font. To the left of the letters is a stylized graphic that resembles a "V" shape, also in black. The graphic is made up of two thick, curved lines that converge at the bottom, creating a sense of movement or flow. The overall design is simple, bold, and modern.
The difference in this submission is:
- With Aloe Vera coated on surgical gloves. a)
The modification of device does not affect the intended use of the device as well as it does not affect its safety and effectiveness. The indication for use and proposed labeling for the device are illustrated in subsequent sections.
The Powder Free, Polymer Coated Brown Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim meets all the requirements of ASTM standard D 3577 - 06 and FDA 21 CFR 800.20.
6.0 Intended Use of the Device:
The Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile with Aloe Vera and with Protein Content Labeling Claim are made of natural rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.
7.0 Summary of Technological Characteristics for the Modified Device:
The Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile with Aloe Vera and with Protein Content Labeling Claim are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICEPERFORMANCE |
|---|---|---|
| Dimensions | ASTM D 3577 - 06 | Meets |
| Physical Properties | ASTM D 3577 - 06 | Meets |
| Freedom from pinholes | ASTM D 3577 - 06FDA 21 CFR 800.20 | Meets |
| Powder Residual | ASTM D 6124 - 06 | Meets< 2 mg/glove |
| Protein Level | ASTM D 5712-99 | < 50 µg/g |
| Biocompatability | Primary Skin Irritation in Rabbits | Passes(Not a primary skin irritant) |
| Dermal Sensitization | Passes(Not a contact sensitizer) |
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Image /page/2/Picture/0 description: The image shows a logo with the letters "WRP" in bold, black font. To the left of the letters is a stylized graphic that resembles a "V" shape, also in black. The graphic has a textured appearance, with some areas appearing slightly faded or pixelated. The overall impression is of a professional and established brand identity.
8.0 Conclusion:
n '
:
and the comments of
The Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile with Aloe Vera and with Protein Content Labeling Claim will perform according to the glove performance standards referenced in section 7 above and meet ASTM standards, and FDA requirements for waterleak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 2007
Mr. Kirk Penner Head of Department, Regulatory Affairs WRP Asia Pacific Sdn Bhd Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi 43900 Sepang Selangor Darul Ehsan MALAYSIA
Re: K070619
Trade/Device Name: Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 Micrograms or Less) Regulation Number: 21 CFR 880.4460 Regulation Name: Surgeon's Gloves Regulatory Class: I Product Code: KGO Dated: June 4, 2007 Received: June 13, 2007
Dear Mr. Penner:
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.
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Page 2 - Mr. Penner
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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Sagite y. Michie Ows.
Chiu Lin, Ph.D. 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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Image /page/5/Picture/0 description: The image shows a logo with the letters "VWRP" in a bold, stylized font. The letters are black and appear to have a textured or slightly distressed effect. The "V" and "W" are connected, creating a unique visual element, while the "R" and "P" are separate. The overall design is simple yet impactful, suggesting a strong and established brand identity.
INDICATIONS FOR USE
Applicant:
WRP Asia Pacific Sdn Bhd
510(k) Number (if known):
$\mathcal{A} \mathcal{K} 70619
Device Name:
POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE, WITH ALOE VERA AND WITH COATED PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
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)
Sheela H. Murphy/10
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
OR
510(k) Number: K070614
Prescription Use (Per 21 CFR 801.109) Over-The-Counter
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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).