(410 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.
Powder Free Nitrile Examination Glove, Black and dual color White-Blue are Class 1 Patient Examination Gloves. The dual color White-Blue is made dual color by double dipping. They are ambidextrous and come in different sizes, Extra Small, Small, Medium, Large and Extra Large, Double Extra-Large and Triple Extra-Large.
This document describes the premarket notification (510(k)) for Powder Free Nitrile Examination Gloves (Black and Dual Color White-Blue) from Careplus (M) SDN BHD. This is for an examination glove, a Class I reserved device (21 CFR 880.6250) intended for medical purposes to prevent contamination between patient and examiner.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Standard Reference | Standard Specification | Device Performance (Black Glove) | Device Performance (White-Blue Glove) | Predicate Device Performance |
|---|---|---|---|---|---|
| Product Code | - | LZA, 21 CFR 880.6250 | LZA, 21 CFR 880.6250 | LZA, 21 CFR 880.6250 | LZA, 21 CFR 880.6250 |
| Class | - | I | I | I | I |
| Material | - | Nitrile | Nitrile | Nitrile | Nitrile |
| Color | - | - | Black | White-Blue | Blue, White |
| White Pigment | - | Titanium Dioxide | Titanium Dioxide | Titanium Dioxide | Titanium Dioxide |
| Size | ASTM D6319-19 | - | XS,S,M,L,XL, XXL,XXXL | XS,S,M,L,XL, XXL,XXXL | XS,S,M,L,XL |
| Water Tight Test | ASTM D6319-19, ASTM D5151-06 | G-I, AQL 2.5 | Meets specification | Meets specification | Meets specification |
| Physical Properties (Before Aging) | |||||
| Tensile Strength | ASTM D6319-19 | Min. 14 Mpa | Meets specification (min. 25 Mpa) | Meets specification (min. 25 Mpa) | Meets specification |
| Ultimate Elongation | ASTM D6319-19 | Min. 500 % | Meets specification (min. 605 %) | Meets specification (min. 606 %) | Meets specification |
| Physical Properties (After Aging) | |||||
| Tensile Strength | ASTM D6319-19 | Min. 14 Mpa | Meets specification (min. 29 Mpa) | Meets specification (min. 26 Mpa) | Meets specification |
| Ultimate Elongation | ASTM D6319-19 | Min. 500 % (should be 400 min based on table 6) | Meets specification (min. 559 %) | Meets specification (min. 576 %) | Meets specification |
| Powder Content | ASTM D6319-19, ASTM D6124-06 | Max. 2 mg/glove | Meets specification (Max. 1.02) | Meets specification (Max. 0.90) | Meets specification |
| Biocompatibility Tests | |||||
| Primary Skin Irritation Test | ISO 10993-10 | - | No irritant response | No irritant response | No irritant response |
| Dermal Sensitization Test | ISO 10993-10 | - | No skin sensitization effect | No skin sensitization effect | No skin sensitization effect |
| Acute Systemic Toxicity | ISO 10993-11 | - | No revelation of toxicity | No revelation of toxicity | No revelation of toxicity |
| In vitro Cytotoxicity Test | ISO 10993-5 | Cytotox at undiluted, 1:2 (Black); undiluted, 1:2, 1:4, 1:8 (White-Blue) | Varies by dilution, non-cytotoxic at higher dilutions | Varies by dilution, non-cytotoxic at higher dilutions | Varies by dilution, non-cytotoxic at higher dilutions |
| Freedom from pin-holes | ASTM D6319-19 | AQL 2.5 | 1.5 and below | 1.5 and below | 1.5 and below |
| Dimensions | |||||
| Width, mm | ASTM D6319-19 | XS - 70 ± 10, etc. | Within specification | Within specification | Meet Specification |
| Length, mm | ASTM D6319-19 | XS - 220 min, etc. | Within specification | Within specification | Meet Specification |
| Thickness Palm, mm | ASTM D6319-19 | XS - 0.05 min, etc. | Within specification (e.g., min 0.13) | Within specification (e.g., min 0.15) | Meet Specification |
| Thickness Finger, mm | ASTM D6319-19 | XS - 0.05 min, etc. | Within specification (e.g., min 0.18) | Within specification (e.g., min 0.19) | Meet Specification |
| Single Use | - | Single Use | Single Use | Single Use | Single Use |
| Labeling | - | Single Use | Single Use | Single Use | Single Use |
| Intended Use | - | As defined (medical purposes) | Same as predicate | Same as predicate | Same as predicate |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes used for each test. Instead, it indicates that the "performance test data from the non-clinical test met the specifications from ASTM testing methodology." ASTM standards for examination gloves (like D6319-19) typically define sampling plans for various tests (e.g., AQL for pinholes).
The data provenance is not specified beyond being generated by the device manufacturer, Careplus (M) SDN BHD, located in Seremban, Negeri Sembilan Darul Khusus, Malaysia. The studies are prospective in the sense that they were conducted to test the performance of the specific subject devices.
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)
This section is not applicable as the device is an examination glove, not an AI or diagnostic imaging device that requires expert interpretation to establish a "ground truth" for a test set. Its performance is evaluated against physical and chemical specifications and biocompatibility standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. The performance evaluation for examination gloves typically involves objective measurements and scientific testing against established standards, not subjective adjudication by experts on a test set as would be found in AI/diagnostic studies.
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 section is not applicable. The device is an examination glove, not an AI-assisted diagnostic tool. Therefore, MRMC studies are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical product (an examination glove), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by objective measurements and adherence to recognized international standards such as ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application) and ISO 10993 (Biological evaluation of medical devices for biocompatibility). For example:
- Pin-hole detection is measured against an Acceptable Quality Level (AQL).
- Physical properties like tensile strength, elongation, and dimensions are tested against minimum/maximum values specified in the ASTM standard.
- Biocompatibility is assessed through standardized tests (e.g., skin irritation, sensitization, acute systemic toxicity, in vitro cytotoxicity) as per ISO 10993, with predefined criteria for "no irritant response," "no skin sensitization effect," etc.
8. The sample size for the training set
This section is not applicable. The device is a physical product, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as point 8.
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August 20, 2021
Careplus (M) SDN BHD Bee Khoo Quality Manager Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate Seremban. 70450 Mv
Re: K201857
Trade/Device Name: Powder Free Nitrile Examination Glove Black and Dual Color White-Blue Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: July 8, 2021 Received: July 12, 2021
Dear Bee Khoo:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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 of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201857
Device Name
Powder Free Nitrile Examination Glove Black and Dual Color White-Blue
Indications for Use (Describe)
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 (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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K201857
510(K) SUMMARY
- 1.0 Applicant: CAREPLUS (M) SDN BHD
Address: Lot 120 & 121 . Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia.
Phone No. 60-6-6772781 Fax No. 60-6-6772780
Contact Person Lim Kwee Shyan
- 2.0 Date of Summary 18th June, 2021
- 3.0 Device Information Device Name
POWDER FREE NITRILE EXAMINATION GLOVE BLACK AND DUAL COLOR WHITE-BLUE
| Common Name | : Exam Gloves |
|---|---|
| Classification Name | : Patient Examination Gloves (21 CFR 880.6250, LZA) |
| Classification Panel | : Non-powdered patient examination glove |
| Class | : I |
4.0 Predicate Device
Predicate device: Powder Free Nitrile Examination Glove White, 510(k) number K142858 and Powder Free Nitrile Examination Glove Blue, 510(k) number K142862, product code LZA.
5.0 Device Description
Powder Free Nitrile Examination Glove, Black and dual color White-Blue are Class 1 Patient Examination Gloves. The dual color White-Blue is made dual color by double dipping. They are ambidextrous and come in different sizes, Extra Small, Small, Medium, Large and Extra Large, Double Extra-Large and Triple Extra-Large. Gloves meet the ASTM D6319-19 specification below:
| Size | XS | S | M | L | XL | XXL | XXXL |
|---|---|---|---|---|---|---|---|
| Length, min. mm | 220 | 230 | NA | ||||
| Thickness, min. mm | |||||||
| finger | 0.05 | NA | |||||
| palm | 0.05 | ||||||
| Width, ± 10 mm | 70 | 80 | 95 | 110 | 120 | NA |
6.0 Indications for Use Statement
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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K201857
7.0 Technological Characteristics
Following is a table summarized the technological characteristics compared to Predicate Device and equivalent standards:
| Parameter | StandardReference | StandardSpecification | Subject Glove(Powder FreeNitrile ExaminationGlove, Black)K201857 | Subject Glove(Powder FreeNitrile ExaminationGlove, Dual ColorWhite-Blue)K201857 | Predicate Device(Nitrile Blue,K142862Nitrile White,K142858) | Characteristics |
|---|---|---|---|---|---|---|
| Product CodeRegulation number | - | - | LZA21 CFR 880.6250 | LZA21 CFR 880.6250 | LZA21 CFR 880.6250 | Same |
| Class | - | - | I | I | I | Same |
| Material | - | - | Nitrile | Nitrile | Nitrile | Same |
| Color | - | - | Black | White-Blue | Blue, White | Similar |
| White Pigment | - | - | Titanium Dioxide | Titanium Dioxide | Titanium Dioxide | Same |
| Size | ASTMD6319-19 | - | XS,S,M,L,XL, XXL,XXXL | XS,S,M,L,XL, XXL,XXXL | XS,S,M,L,XL | Similar |
| Water Tight Test,1000ml | ASTMD6319-19ASTMD5151-06 | G-I, AQL 2.5 | Meets specification | Meets specification | Meets specification | Same |
| Physical Propertiesi) Before AgeingTensile StrengthUltimate Elongation | ASTMD6319-19 | Min. 14 MpaMin. 500 % | Meets specification | Meets specification | Meets specification | Same |
| ii) After Ageingii)Tensile StrengthUltimate Elongation | ASTMD6319-19 | Min. 14 MpaMin. 500 | Meets specification | Meets specification | Meets specification | Same |
| Powder Content | ASTMD6319-19ASTMD6124-06 | Max.2 mg/glove | Meets specification | Meets specification | Meets specification | Same |
| BiocompatabilityTesti) Primary SkinIrritation Test | ISO 10993-10 | Conclusion: Underthe conditions of thisstudy, the testmaterial did notcause and irritantresponse. | Conclusion: Underthe conditions of thisstudy, the testmaterial did notcause and irritantresponse. | Conclusion: Underthe conditions of thisstudy, the testmaterial did notcause and irritantresponse. | Same | |
| ii) DermalSensitization Test | ISO 10993-10 | Conclusion: Underthe conditions of thisstudy, the testmaterial did notproduce a skinsensitization effect. | Conclusion: Underthe conditions of thisstudy, the testmaterial did notproduce a skinsensitization effect. | Conclusion: Underthe conditions of thisstudy, the testmaterial did notproduce a skinsensitization effect. | Same | |
| iii) Acute SystemicToxicity | ISO 10993-11 | Conclusion: Underthe conditions of thisstudy, the testmaterial both innerand outer surfacedid not reveal | Conclusion: Underthe conditions of thisstudy, the testmaterial both innerand outer surfacedid not reveal | Conclusion: Underthe conditions of thisstudy, the testmaterial both innerand outer surfacedid not reveal | Same |
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K201857
| iv) In vitro CytotoxicityTest | ISO 10993-5 | Conclusions: Underthe conditions of thisstudy, the testmaterial isCytotox(grade >2) atundiluted, 1:2, andNon-cyctotoxic,grade ≤2 at dilutions1:4, 1:8;1:16,1:32and 1:64 | Conclusions: Underthe conditions of thisstudy, the testmaterial isCytotox(grade >2) atundiluted, 1:2, 1:4,1:8 and Non-cyctotoxic, grade ≤2at dilutions;1:16,1:32and 1:64 | White Nitrile:Conclusions: Underthe conditions of thisstudy, the testmaterial isCytotox(grade >2) atundiluted, 1:2, 1:4and Non-cyctotoxic,grade ≤2 atdilutions, 1:8 ,1:16,1:32 and 1:64Blue Nitrile:Conclusions: Underthe conditions of thisstudy, the testmaterial isCytotox(grade >2) atundiluted, 1:2, 1:4,1:8, 1:16 and Non-cyctotoxic, grade ≤2at dilutions;1:32 and1:64 | Similar |
|---|---|---|---|---|---|
| Single Use | - | Single Use | Single Use | Single Use | Same |
| Labeling | - | Single Use | Single Use | Single Use | Same |
| Intended Use | - | A patientexamination glovesis a disposal deviceintended for medicalpurposes that isworn on theexaminer's hand orfinger to preventcontaminationbetween patient andexaminer. | A patientexamination glovesis a disposal deviceintended for medicalpurposes that isworn on theexaminer's hand orfinger to preventcontaminationbetween patient andexaminer. | A patientexamination glovesis a disposal deviceintended for medicalpurposes that isworn on theexaminer's hand orfinger to preventcontaminationbetween patient andexaminer. | Same |
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| Parameter | Standard References | Standard Specification | Device PerformanceBlack | Device PerformanceWhite-Blue | Predicate Device |
|---|---|---|---|---|---|
| Freedom from pin-holes | ASTM D6319-19 | AQL 2.5 | 1.5 and below | 1.5 and below | 1.5 and below |
| Width, mm | ASTM D6319-19 | XS - 70 ± 10S - 80 ± 10M - 95 ± 10L - 110 ± 10XL- 120 ± 10XXL- NAXXXL- NA | 78- 8086- 8896- 98106- 108116- 118120- 125126- 129 | 78- 8086- 8895- 98107- 108115- 117122- 123129- 132 | Meet Specification |
| Length, mm | ASTM D6319-19 | XS - 220 minS - 220 minM - 230 minL - 230 minXL- 230 minXXL- NAXXXL- NA | min. 293min. 285min. 287min. 281min. 282min. 292min. 290 | min. 297min. 285min. 285min. 286min. 301min. 289min. 300 | Meet Specification |
| Thickness Palm, mm | ASTM D6319-19 | XS – 0.05 minS - 0.05 minM - 0.05 minL - 0.05 minXL- 0.05 minXXL- NAXXXL- NA | min. 0.13min. 0.15min. 0.15min. 0.16min. 0.15min. 0.12min. 0.13 | min. 0.15min. 0.16min. 0.15min. 0.15min. 0.14min. 0.16min. 0.14 | Meet Specification |
| Thickness Finger, mm | ASTM D6319-19 | XS – 0.05 minS - 0.05 minM - 0.05 minL - 0.05 minXL- 0.05 minXXL- NAXXXL- NA | min. 0.18min. 0.21min. 0.21min. 0.18min. 0.21min. 0.16min. 0.20 | min. 0.19min. 0.20min. 0.19min. 0.20min. 0.20min. 0.20min. 0.19 | Meet Specification |
| Tensile Strength Before aging, Mpa | ASTM D6319-19 | 14 min | min. 25 | min. 25 | Meet Specification |
| Tensile Strength After aging, Mpa | ASTM D6319-19 | 14 min | min. 29 | min. 26 | Meet Specification |
| Ultimate Elongation Before aging,% | ASTM D6319-19 | 500 min | min. 605 | min. 606 | Meet Specification |
| Ultimate Elongation After aging,% | ASTM D6319-19 | 400 min | min. 559 | min. 576 | Meet Specification |
| Powder Free | ASTM D6319-19 | Max. 2 | Max. 1.02 | Max. 0.90 | Meet Specification |
Summary of Non-Clinical Testing 8.0
The performance test data from the non-clinical test met the specifications from ASTM testing methodology.
Summary of Clinical Testing 9.0
Clinical data is not needed for medical gloves or of most devices cleared by the 510(k) process.
10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices.
§ 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.