(240 days)
A powder free Nitrile Examination glove is a disposable device made of synthetic material that is worn on the hand for medical purposes to prevent contamination between patient and examiner.
The Powder Free Nitrile Examination Glove White Colored Class I patient examination gloves, Nitrile-80 LZA, will meet all the current specification for ASTM D6319-00a (Reapproved 2005)
This document is a 510(k) summary for a medical device called "POWDER FREE NITRILE EXAMINATION GLOVE WHITE COLORED." It outlines the device's characteristics, intended use, and its substantial equivalence to a legally marketed predicate device.
Here's an analysis of the provided information, structured around your questions, though it's important to note that many of your specific questions about study design (like sample sizes, expert qualifications, adjudication methods, MRMC studies, training set details) are not applicable to this type of device submission. This is a submission for a Class I medical device (patient examination glove), which typically relies on established performance standards rather than complex clinical studies or AI algorithm evaluations.
1. A table of acceptance criteria and the reported device performance
| Characteristic | Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-00a (Reapproved 2005) | Meets |
| Physical Properties | ASTM D 412-98 (Reapproved 2002) | Meets |
| Freedom From pin-holes | ASTM D 5151-06 | Meets |
| Powder Free Residue | ASTM D 6124-06 | Meets |
| Biocompatibility | Dermal Sensitization in the guinea pig (as per ISO 10993-10:2007(E)) | Passes - Not a Dermal Sensitization |
| Biocompatibility | Primary Skin Irritation Test in rabbits (as per Consumer Product Safety Commission, Title 16, Chapter II, Part 1500:41 & 1500:3(c)(4)) | Passes - Not a Primary Skin irritant |
| General Requirements | ASTM D 6319-00a Standard Specification for Nitrile Examination Gloves for Medical Application, and 21 CFR 800.20 (for water leak test on pinhole AQL) | Meets all current ASTM D 6319-00a requirements |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify exact sample sizes for each test. For standards like ASTM D 6319-00a, ASTM D 5151-06, etc., the standards themselves define the sampling plans (e.g., AQL levels for pinholes) and test methodologies. Without access to the actual test reports, specific sample sizes cannot be determined from this summary.
- Data Provenance: Not explicitly stated, but the submitter is Central Medicare Sdn. Bhd. located in Malaysia. It is implied that the testing was conducted to meet international and US standards. The biocompatibility tests mention ISO 10993-10:2007 (E) and Consumer Product Safety Commission guidelines, which are international and US standards, respectively.
- Retrospective or Prospective: These tests are laboratory-based performance and biocompatibility assessments, conducted prospectively for the purpose of this submission to demonstrate compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable. For a patient examination glove, "ground truth" as you might define it for an AI or diagnostic device does not apply. Performance is assessed against defined physical, chemical, and biological standards through laboratory testing, not expert interpretation of complex data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are not relevant for the type of objective laboratory tests conducted for this device. The tests have clear pass/fail criteria based on the specified standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This device is a physical medical glove, not an AI or diagnostic imaging system. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device has no algorithmic component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Objective Standards and Laboratory Results: The "ground truth" for this device's performance is defined by the objective pass/fail criteria established within recognized international and US standards (ASTM D 6319-00a, ASTM D 412-98, ASTM D 5151-06, ASTM D 6124-06, ISO 10993-10, CPSC guidelines) and the reproducible results obtained from laboratory testing against these standards.
- For biocompatibility, the "ground truth" is the absence of dermal sensitization or primary skin irritation based on standardized animal models.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI or machine learning device. The product development process involves design, manufacturing, and testing according to established engineering and quality control principles.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
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K.103734
AUG 1 9 2011
510 (k) Summary
POWDER FREE NITRILE EXAMINATION GLOVE WHITE COLORED
| 1.0 | Submitter's Name | : | Central Medicare Sdn. Bhd. |
|---|---|---|---|
| 2.0 | Submitter's Address | : | PT 2609-2620 Bt 8, Jalan Changkat JongMukim Changkat Jong36000 Teluk Intan, PerakMalaysia. |
| 3.0 | Telephone No. | : | 605-6231220 |
| 4.0 | Fax No. | : | 605-6231230 |
| 5.0 | Contact Person | : | Mr. K. F Cheong |
| 6.0 | Date of Preparation | : | 9th Feb 2011 |
| 7.0 | Name of Device | : | Powder Free Nitrile Examination Glove White Colored |
| Size | Model Number |
|---|---|
| Extra Small | WPF-35XS |
| Small | WPF-35S |
| Medium | WPF-35M |
| Large | WPF-35L |
| Extra Large | WPF-35XL |
Proprietary/Trade Name :
Common Name
Product Code
Powder Free Nitrile Examination Glove
Other clients private labeling .
Nitrile Examination Glove .
Classification Name : Patient Examination Glove
LZA
Device Classification I . .
Regulation Number 21 CFR 880.6250 .
.
8.0 Identification of The Legally Marketed Device:
The Powder Free Nitrile Examination Glove, White Colored Class 1 patient examination gloves, Nitrile-80 LZA, meets all of the requirements of ASTM, D 6319-00a (Reapproved 2005) Standard Specification for Nitrile Examination Gloves for Medical Application.
Predicate device: Blue Nitrile Examination Gloves, Powder Free (K093696)
9.0 Description of Device:
The Powder Free Nitrile Examination Glove White Colored Class I patient examination gloves, Nitrile-80 LZA, will meet all the current specification for ASTM D6319-00a (Reapproved 2005)
Page 1 of 2 (Rev 02)
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10.0 Intended Use of the Device:
The Powder Free Nitrile Examination Glove, White Colored is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
11.0 Summary of The Technological Characteristics of New Device Compared to The Predicate Device:
There is no different technology characteristic. Gloves are made from nitrile compound (dispersion of butadiene acrylonitrile copolymer) and the initial products are powder free nitrile examination gloves. The Powder Free Nitrile Examination Glove, White Colored possesses the following technological characteristic (as compared to ASTM or equivalent standards):
| Characteristic | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-00a (Reapproved 2005) | Meets |
| Physical Properties | ASTM D 412-98 (Reapproved 2002) | Meets |
| Freedom From pin-holes | ASTM D 5151-06 | Meets |
| Powder Free Residue | ASTM D 6124-06 | Meets |
| Biocompatibility | Dermal Sensitization in the guinea pig(as per ISO 10993-10:2007(E) | PassesNot a Dermal Sensitization |
| Primary Skin Irritation Test in rabbits(as per Consumer Product SafetyCommission, Title 16, Chapter II, Part1500:41 & 1500:3(c)(4)): | PassesNot a Primary Skin irritant |
12.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data
Testing performed per ASTM D 6319-00a Standard Specification for Nitrile Examination Gloves for Medical Application and 21 CFR 800.20. Gloves meet all the current ASTM D 6319-00a.
Primary skin irritation testing in the rabbit and delayed dermal contact sensitization study in the guinea pigs indicate no irritation or sensitization.
13.0 Brief description of Clinical Tests
No new clinical tests were conducted under this 510(k).
14.0 Conclusions Drawn from the Non-Clinical and Clinical Tests.
It can be concluded that the Powder Free Nitrile Examination Glove, White Colored meet the ASTM standard or equivalent standard and FDA requirements for water leak test on pinhole AQL, meet labeling claims. It is as safe as effective, and performed as well the legally marketed indentified in clause 8.0.
Page 2 of 2 (Rev 02)
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Central Medicare SDN BHD C/O Mr. Nick Wang Encompass Medical Supplies 1930 Brea Canyon Road # 240, Diamond Bar Diamond Bar, California 91765
AUG 1 9 2011
Re: K103734
Trade/Device Name: Powder Free Nitrile Examination Gloves White Colored Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: August 12, 2011 Received: August 15, 2011
Dear Mr. Wang:
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: CDRH 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. Wang
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm 1 1 5809.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-firee number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Jh for
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
:
Applicant :
Central Medicare Sdn. Bhd.
K 103734
510(k) Number (if known):
Device Name :
Powder Free Nitrile Examination Gloves White Colored.
| Size | Model Number |
|---|---|
| Extra Small | WPF-35XS |
| Small | WPF-35S |
| Medium | WPF-35M |
| Large | WPF-35L |
| Extra Large | WPF-35XL |
Indication For Use :
A powder free Nitrile Examination glove is a disposable device made of synthetic material that is worn on the hand for medical purposes to prevent contamination between patient and examiner.
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 IF NEEDED)
Concurrent of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K103734 |
|---|---|
| ---------------- | --------- |
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(Rev C)of 5 ev 03)
§ 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.