(107 days)
A 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.
It is the powder-free variation of the class I latex patient examination gloves made by online polymer-coating and on-line chlorination process. The process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. It is particularly suitable to users who prefer a powder-free work environment or who may be sensitive to the powdered version of the same gloves.
The provided text describes the acceptance criteria and performance of a medical device, specifically a "Powder Free Nitrile Examination Glove, Blue (Colored)". The device is being submitted for 510(k) premarket notification to establish substantial equivalence to a legally marketed predicate device.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard / Regulation | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Water Tight Test, 1000 ml | ASTM D6319-10, ASTM D5151-06 | G-I, AQL 2.5 (FDA GII, AQL 2.5) | Meets ASTM D6319-10, Meets ASTM D5151-06 |
| Physical Properties | ASTM D6319-10 | ||
| * Before Ageing: | |||
| - Tensile Strength | Min. 14 Mpa | Meets ASTM D6319-10 | |
| - Ultimate Elongation | Min. 500 % | Meets ASTM D6319-10 | |
| * After Ageing: | |||
| - Tensile Strength | Min. 14 Mpa | Meets ASTM D6319-10 | |
| - Ultimate Elongation | Min. 400 % | Meets ASTM D6319-10 | |
| Powder Content | ASTM D6319-10, ASTM D6124-06 | Max. 2mg/glove | Meets ASTM D6319-10, Meets ASTM D6124-06 |
| Biocompatibility Test | |||
| - Primary Skin Irritation Test | ISO 10993-10 (For sens.), 16CFR Part 1500 (For irrit.) | No Animal Irritation | Passes, Did not cause an irritant response |
| - Dermal Sensitization Test | ISO 10993-10 | No Animal Sensitization | Passes, Did not produce a skin sensitization effect |
| Dimensions | ASTM D6319-10 | Meet Specification | Meet Specification |
| Freedom from pin-holes | ASTM D5151-06 | Meet Specification | Meet Specification |
| Powder Free Residue | ASTM D6124-06, ASTM D6319-10 | Meet Specification | Meet Specification |
2. Sample Size Used for the Test Set and Data Provenance
- The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for water tightness, physical properties, or powder content).
- For biocompatibility tests, it mentions "No Animal Irritation" and "No Animal Sensitization," implying animal studies were conducted, but the number of animals or the specific details of the studies are not provided.
- Data Provenance: The manufacturing company is "Careplus (M) SDN BHD" located in Malaysia. The tests were presumably conducted as part of their manufacturing and quality control process. The studies appear to be prospective as they are conducted to demonstrate the performance of the device for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This information is not provided in the document. The "ground truth" for these types of physical and biocompatibility tests on medical gloves is typically established by laboratory testing against defined ASTM and ISO standards, rather than expert consensus on subjective data.
4. Adjudication Method for the Test Set
- This information is not applicable for the type of tests conducted. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or image-based diagnostics where human readers interpret data, and discrepancies need to be resolved. The tests mentioned here are objective laboratory measurements.
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
- This information is not applicable to this device. This document describes a physical medical device (examination gloves), not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- This information is not applicable to this device, as it is not an algorithm or AI system.
7. The Type of Ground Truth Used
- The ground truth for this device's performance is established by objective measurements against established national and international standards. These include:
- Physical Property Standards: ASTM D6319-10, ASTM D5151-06, ASTM D6124-06
- Biocompatibility Standards: ISO 10993-10, 16CFR Part 1500
- The results are compared directly to the quantitative requirements specified in these standards.
8. The Sample Size for the Training Set
- This information is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable for the same reason as point 8.
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Image /page/0/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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 16, 2015
Careplus (M) SDN BHD Mr. Lim Kwee Shyan Managing Director Lot 120 & 121 Jalan Senawang 3 Senawang Industrial Estate 70450 Seremban Negeri Sembilan Darul Khusus MALAYSIA
Re: K142862
Trade/Device Name: Powder Free Nitrile Examination Glove, Blue (Colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient examination glove Regulatory Class: I Product Code: LZA Dated: December 1, 2014 Received: December 3, 2014
Dear Mr. Shyan:
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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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 Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, 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): K142862
Device Name: Powder Free Nitrile Examination Glove, Blue (Colored)
Indications for Use: A 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.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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Image /page/3/Picture/0 description: The image is a logo with a white square background. Inside the square, there is a gray vertical rectangle on the left side and a red semi-circle on the right side. The semi-circle is positioned such that it forms the letter 'P' when combined with the gray rectangle. There is a black shadow underneath the square.
AREPLUS (M) SDN BHD (Company No. 212677-K)
ng Industrial Estate, 70450 Seremban, Negeri Sembilan Darul Khusus. Malaysia. Fax: 60-6-6772780 Tel: 60-6-6772781
E-mail: info@careplus.com
Quality and Relationship You Can Trust
510(K) SUMMARY
510(k) No.: K142862
-
CAREPLUS (M) SDN BHD 1.0 Applicant: Address: Lot 120 & 121 , Jalan Senawang Senawang Industrial Estate,
70450 Seremban, Negeri Sembilan Darul Khusus. Malaysia. -
Phone No.: 60-6-6772781 Fax No. 60-6-6772780
-
2.0 Lim Kwee Shvan Contact Person: Phone No.: 60-6-6772781 Fax No. 60-6-6772780
-
Preparation Date: 16th January, 2015 3.0
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4.0 Device Information
Device Name: POWDER FREE NITRILE EXAMINATION GLOVE, BLUE(COLORED) Common Name: POWDER FREE NITRILE EXAMINATION GLOVE Classification Name: Patient Examination Gloves
5.0 Claim of Equivalence
The device is a class I latex patient examination gloves 21 CFR 880.6250, Patient Examination Glove, LZA which is made powder-free by a process of on-line polymercoating and chlorination which is substantially equivalent in safety and effectiveness to the predicate device Powder Free Nitrile Examination Glove Blue and White Colored, Nonsterile 510(k) number K123469, product code LZA.
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6.0 Device Description
It is the powder-free variation of the class I latex patient examination gloves made by online polymer-coating and on-line chlorination process. The process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. It is particularly suitable to users who prefer a powder-free work environment or who may be sensitive to the powdered version of the same gloves. -
7.0 Intended Use of Device
A 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.
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Image /page/4/Picture/0 description: The image is a logo that features a square with a thick black border. Inside the square, there is a gray vertical rectangle on the left side and a red semi-circle on the right side. The semi-circle is positioned so that its flat edge aligns with the right edge of the gray rectangle, creating a shape that resembles the letter 'P'.
CAREPLUS (M) SDN BHD (company No. 212677-K)
Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia. Tel: 60-6-6772781 Fax: 60-6-6772780
E-mail: info@careplus.com
Quality and Relationship You Can Trust
8.0 1)Comparison To Predicate Device
| No. | Characteristic | Standards | Related Defects | Predicate Device(Powder Free NitrileExamination Glove,Blue and WhiteColored K123469) | Powder-Free NitrileExamination Glove(Blue Color) |
|---|---|---|---|---|---|
| 1 | Water Tight Test,1000 ml | ASTM D6319-10ASTM D5151-06 | G- I, AQL2.5(FDA GII,AQL 2.5) | Meets ASTM D6319-10Meets ASTM D5151-06 | Meets ASTM D6319-10Meets ASTM D5151-06 |
| 2 | Physical Properties(Before Ageing)i) Tensile Strength(Mpa)ii)Ultimate Elongation(%)(After Ageing)i) Tensile Strength(Mpa)ii) Ultimate Elongation(%) | ASTM D6319-10 | Min. 14Min. 500Min. 14Min. 400 | Meets ASTM D6319-10Meets ASTM D6319-10Meets ASTM D6319-10Meets ASTM D6319-10 | Meets ASTM D6319-10Meets ASTM D6319-10Meets ASTM D6319-10Meets ASTM D6319-10 |
| 3 | Powder Content | ASTM D6319-10ASTM D6124-06 | Max.2mg/glove | Meets ASTM D6319-10Meets ASTM D6124-06 | Meets ASTM D6319-10Meets ASTM D6124-06 |
| 4 | Biocompatibility Testi) Primary Skin IrritationTestii)Dermal SensitizationTest | ISO 10993-10As per 16CFRPart 1500 | No AnimalIrritationNo AnimalIrritation | Passesi) Primary SkinIrritation Test.Conclusion: Under theconditions of this study,the test material did notcause an irritantresponse.ii)Dermal SensitizationTest.Conclusion: Under theconditions of this study,the test material did notproduce a skinsensitization effect. | Passesi) Primary Skin Irritation Test.Conclusion: Under theconditions of this study,the test material did notcause an irritantresponse.ii)Dermal SensitizationTest.Conclusion: Under theconditions of this study,the test material did notproduce a skinsensitization effect. |
| 5 | Color Extraction | Blue | Blue |
Conclusions:
Careplus (M) Sdn Bhd, Powder Free Nitrile Examination Glove, Blue (colored) is similar with Wear Safe (M) Sdn Bhd, Powder Free Nitrile Examination Glove, Blue and White Colored, K123469.
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Image /page/5/Picture/0 description: The image is a logo that features a square divided into two distinct sections. On the left side, there is a gray vertical rectangle. On the right side, there is a red semi-circle. The logo has a simple and modern design, using only two colors and basic geometric shapes.
CAREPLUS (M) SDN BHD (company No. 212677-K)
Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia. Tel: 60-6-6772781 Fax: 60-6-6772780
E-mail: info@careplus.com
Quality and Relationship You Can Trust
2) Summary of Technological Characteristics of the Device
Powder Free Nitrile Examination Glove, Blue(Colored) possesses the following technological characteristic (as compared to ASTM or equivalent standards):
| Parameter | Standard References | Device Performance |
|---|---|---|
| Dimensions | ASTM D6319-10 | Meet Specification |
| Physical Properties | ASTM D6319-10 | Meet Specification |
| Freedom from pin-holes | ASTM D5151-06 | Meet Specification |
| Powder Free Residue | ASTM D6124-06 | Meet Specification |
| ASTM D6319-10 | Meet Specification | |
| Biocompatability Test | Dermal SensitizationTest(ISO 10993-10:2010) | Not a contact skinsensitizer |
| Primary Skin IrritationTest(As per 16CFR Part 1500) | Not a primary skinirritant |
9.0 Conclusion
Powder Free Nitrile Examination Glove, Blue(Colored) performs according to the glove performance standards referenced in Section 8.0 above. The device is substantially equivalent to current marketed devices per Section 5.0.
§ 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.