(196 days)
The powder free examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or forefinger to prevent contamination between examiner and patient bodily fluids, waste or environment.
Powder Free Nitrile Examination Gloves, Blue meet all the requirements of ASTM standard D6319-00a, D6124-06 and FDA 21 CFR 880.6250.
Acceptance Criteria and Device Performance Study for DERMAGRIP ULTRA Powder Free Blue Nitrile Patient Examination Gloves
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard | Acceptance Criteria | Reported Device Performance (Current Device) |
|---|---|---|---|
| Dimensions | ASTM D6319-10 | Meets (Implicitly, as the standard specifies dimensional requirements for various sizes of examination gloves) | Meets |
| Physical Properties | ASTM D6319-10 | Meets (Implicitly, the standard outlines requirements for tensile strength, elongation, and ultimate elongation) | Meets |
| Thickness | ASTM D6319-10 | Meets (Implicitly, the standard specifies minimum and maximum thickness requirements at various points) | Meets |
| Powder Free | ASTM D6124-06 | ≤ 2 mg/glove | Meets (≤ 2 mg/glove) |
| Biocompatibility | Primary Skin Irritation: Consumer Product Safety Commission, Title 16, Chapter II, Part 1500:41 & 1500:3 (c)(4) | Not a primary skin irritant | Passes (Not a primary skin irritant) |
| Dermal Sensitization: Closed Patch Test ISO 10993-10:2002(E) | Not a contact sensitizer | Passes (Not a contact sensitizer) | |
| Watertight (1000ml) | ASTM D5151-06 | Passes (The standard specifies the water leak test and Acceptable Quality Limits (AQL) for pinholes, typically 1.5% AQL or better for medical gloves.) | Passes |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the sample size used for each specific test within the "Non-Clinical Performance Data" section. However, medical device testing, particularly for gloves, involves sampling from production lots. The results are reported as meeting the specified ASTM standards, which themselves define sampling plans and acceptable quality limits (AQL) for various tests.
The data provenance is not specified in terms of country of origin, but the submitter is from Malaysia (Advance Medical Products Sdn Bhd). The study appears to be retrospective, relying on performance data generated during the product development and quality assurance process, rather than a new prospective clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The concept of "experts" establishing ground truth in the traditional sense (e.g., radiologists interpreting images) is not applicable here. The ground truth for this device (examination gloves) is established by adherence to recognized international and national standards (ASTM, ISO, and FDA regulations). These standards are developed and maintained by expert committees in their respective fields (e.g., materials science, toxicology, medical devices).
Therefore, the "ground truth" is the defined requirements and methodologies within these standards. The device's performance is measured against these objective criteria rather than subjective expert consensus on individual cases.
4. Adjudication Method for the Test Set
Adjudication methods like "2+1" or "3+1" are not relevant for the testing of examination gloves as described. The testing involves objective measurements to assess compliance with physical, chemical, and biological standards. Results are typically pass/fail based on predefined thresholds and statistical sampling plans outlined in the respective ASTM and ISO standards (e.g., AQL for pinholes). There is no subjective interpretation requiring an adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to evaluate the impact of a computer-aided diagnostic (CAD) device on human reader performance for tasks like image interpretation. This device is a physical medical device (examination glove), not an AI/CAD system, and its performance is evaluated against objective technical standards, not against human reader performance.
6. Standalone Performance Study
Yes, a standalone performance study was done. The "Device Performance" section and the "Non-Clinical Performance Data" explicitly describe tests conducted on the device itself (DERMAGRIP ULTRA Powder Free Blue Nitrile Examination Gloves) to determine if it meets the specified ASTM and ISO standards for:
- Dimensions
- Physical Properties (e.g., tensile strength, elongation)
- Thickness
- Powder content
- Biocompatibility (skin irritation and sensitization)
- Watertight integrity (pinholes)
These tests evaluate the algorithm-only performance, as the device's function is entirely self-contained within its physical properties and there is no human-in-the-loop interaction in its performance assessment beyond conducting the prescribed standardized tests.
7. Type of Ground Truth Used
The type of ground truth used is objective, standardized measurements and criteria defined by validated industry and regulatory standards. Specifically:
- ASTM (American Society for Testing and Materials) Standards: D6319-10 (for physical properties, dimensions, thickness), D6124-06 (for powder residue), D5151-06 (for watertight integrity/pinholes).
- ISO (International Organization for Standardization) Standard: ISO 10993-10:2002(E) (for dermal sensitization).
- Consumer Product Safety Commission Regulations: Title 16, Chapter II, Part 1500:41 & 1500:3 (c)(4) (for primary skin irritation).
These standards provide the pre-established, empirically validated metrics against which the device's performance is compared.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. This is a physical medical device (examination gloves), not a machine learning or AI model that requires training data. The device's properties are inherent to its manufacturing process and materials.
9. How the Ground Truth for the Training Set Was Established
As stated above, a "training set" is not relevant for this type of device. The "ground truth" for evaluating the performance of examination gloves is established through rigorous, standardized testing methodologies detailed in the ASTM, ISO, and CPSC regulations. These standards define how to measure the intrinsic properties of the glove and the acceptable limits for those properties to ensure safety and effectiveness for its intended use.
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K 11:09:79
OCT 2 0 2011
510(K) summary Page 1 of 2
510(k) SUMMARY
1.0 Submitter:
| Name: | Mr Zahari Darus |
|---|---|
| Address: | Advance Medical Products Sdn BhdLot 8961 & 8964, Batu 19 Jalan Beruas, 32400 Ayer TawarPerak Darul Ridzuan, MALAYSIA |
| Phone No.: | +60-5-6722 688 / +60-5-6727 559 |
| Fax No.: | +60-5-6728 688 |
March 2011 (revised 12 September 2011) Date of Summary Prepared:
2.0 Name of the device:
DERMAGRIP ULTRA Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile (and various brandnames)
Common Name: Exam Gloves
Classification Name: Patient Examination Gloves (21 CFR 880.6250 product code LZA)
3.0 Identification of The Legally Marketed Devices:
Dermagrip Powder Free Blue Nitrile Examination Gloves 510(k) #: K022904 MDL: D36500 Regulatory Class I Product code: LZA
4.0 Description of The Device:
Powder Free Nitrile Examination Gloves, Blue meet all the requirements of ASTM standard D6319-00a, D6124-06 and FDA 21 CFR 880.6250.
5.0 Intended Use of the Device:
The powder free examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or forefinger to prevent contamination between examiner and patient bodily fluids, waste or environment.
6.0 Summary of the Technological Characteristics of the Device:
The Powder Free Nitrile Examination Gloves are summarized with the following technological characteristics compared to ASTM 6319-00a or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE (BothPredicate and Current) |
|---|---|---|
| Dimensions | ASTM D6319-10 | Meets |
| Physical Properties | ASTM D6319-10 | Meets |
| Thickness | ASTM D6319-10 | Meets |
| Powder Free | ASTM D6124-06 | Meets$≤ 2 mg/glove$ |
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K 110979
510(k) SUMMARY
| Biocompatability | Passes | |
|---|---|---|
| Primary Skin Irritation -Consumer product safetyCommission, Title 16,Chapter II, Part 1500:41 &1500:3 (c)(4) | (Not a primary skin irritant) | |
| Dermal Sensitization -Closedpatch Test ISO 10993-10:2002(E) | Passes(Not a contact sensitizer) | |
| Watertight (1000ml) | ASTM D5151-06 | Passes |
*Details and discussions of tests can be found in performance section
7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data
The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above (ASTM Requirements).
8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
9.0 Conclusion
Powder Free Nitrile Examination Gloves, Blue will perform according to the gloves performance standards referenced in section 6.0 above and meet ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, the device is substantially equivalent to currently marketed devices.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with three wavy lines representing snakes or streams.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
OCT 2 0 2011
Mr. Zahari Darus Operations Manager Advance Medical Products SDN BHD Lot 8961 & 8964. Batu 19 Jalan Beruas, 32400 Ayer Tawar Perak Darul Ridzuan, MALAYSIA
Re: K110979
Trade/Device Name: DERMAGRIP ULTRA Powder Free Blue Nitrile Examination Gloves, Non-sterile (and various brandnames) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: September 19, 2011 Received: September 22, 2011
Dear Mr. Darus:
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. Please note: CDNH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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. Darus
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 (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, a
Anthony V. a. Auten
Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use
510(k) Number (if known): K110979
Applicant Name: Advance Medical Products Sdn Bhd
Device Name:
DERMAGRIP ULTRA Powder Free Blue Nitrile Examination Gloves, Non-sterile (and various brandnames)
Indications for Use:
The powder free examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or forefinger to prevent contamination between examiner and patient bodily fluids, waste or environment.
Prescription Use No (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use YES (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)
Edith B. Clarence-Will
Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K110979
Page ___ of
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.