(222 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. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
It is the powder-free variation of the class I latex patient examination gloves made by on-line polymer-coating and mild on-line chlorination process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder.
This is a 510(k) summary for a medical device (Powder Free Nitrile Examination Gloves, Blue, Chemotest), not an AI/ML device. Therefore, the sections regarding AI/ML device assessment criteria (such as sample size for test/training set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable.
The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing.
Here's the relevant information extrapolated from the document regarding acceptance criteria and performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Freedom From Holes | ASTM D6319-19, ASTM D5151-19 | Inspection level G-I, AQL 2.5 | Pass |
| Dimension | ASTM D6319-19 | Length, min. (mm): XSmall 220, Small 220, Medium 230, Large 230, XLarge 230 | Pass (Meets requirements for all sizes) |
| Thickness, min. (mm): 0.05 (palm, finger) | Pass (Meets 0.05mm min) | ||
| Width, ± 10 (mm): XSmall 70, Small 80, Medium 95, Large 110, XLarge 120 | Pass (Meets requirements for all sizes) | ||
| Physical Properties (Before Aging) | ASTM D6319-19 | Tensile Strength: 14 MPa min. | Pass (Meets 14MPa min.) |
| Ultimate Elongation: 500 % min. | Pass (Meets 500% min.) | ||
| Physical Properties (After Accelerated Aging) | ASTM D6319-19 | Tensile Strength: 14 MPa min. | Pass (Meets 14MPa min.) |
| Ultimate Elongation: 400 % min. | Pass (Meets 400% min.) | ||
| Residual Powder Content | ASTM D6319-19, ASTM D6124-06 | Not more than 2 mg per glove | Pass (Meets 2mg/glove max.) |
| Biocompatibility - Primary Skin Irritation Test | ISO 10993-10 | No Irritation | No irritant response |
| Biocompatibility - Skin Sensitization Test | ISO 10993-10 | No Irritation | No skin sensitization effect |
| Biocompatibility - In Vitro Cytotoxicity Test | ISO 10993-5:2009 | (No specific numerical criteria, evaluated for reactivity) | Moderate cytotoxicity reactivity at 6.0 cm²/mL; No cytotoxicity reactivity at 3.0 cm²/mL |
| Biocompatibility - Acute Systemic Toxicity | ISO 10993-11 | (No specific numerical criteria, evaluated for adverse biological reactions) | No adverse biological reaction |
| Chemotherapy Drugs Permeation Time | ASTM D6978-05 | (Breakthrough detection time in minutes per drug) | Carmustine (BCNU): 22.6 min (WARNING: Not recommended for use) Cisplatin: >240 min Cyclophosphamide (Cytoxan): >240 min Dacarbazine: >240 min Doxorubicin HCL: >240 min Etoposide: >240 min Fluorouracil: >240 min Ifosfamide: >240 min Mitoxantrone: >240 min Paclitaxel: >240 min Thio Tepa: 43.9 min (WARNING: Not recommended for use) Vincristine Sulfate: >240 min |
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 sample sizes for each non-clinical test (e.g., number of gloves tested for dimensions, holes, or physical properties). However, it implies that the testing was conducted according to the specified ASTM and ISO standards, which would dictate appropriate sample sizes for each test method.
The data provenance is not explicitly stated in terms of country of origin of the testing data itself, but the applicant is Careglove Global SDN BHD from Malaysia. The studies are non-clinical, laboratory-based tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this is for a physical medical device (examination gloves) and not an AI/ML diagnostic or predictive device requiring ground truth from human experts. The "truth" is established by physical measurement against standard specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept applies primarily to AI/ML clinical studies where human readers might adjudicate discrepancies or define ground truth. For physical device testing, results are measured and compared against established 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, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" or reference values for device performance are defined by recognized international and national standards:
- ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-06 (Standard Test Method for Residue on Medical Gloves)
- ASTM D6978-05 (Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs)
- ISO 10993-10 (Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization)
- ISO 10993-5:2009 (Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity)
- ISO 10993-11 (Biological evaluation of medical devices – Part 11: Tests for systemic toxicity)
The device's performance is compared directly to the specifications outlined in these standards.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device and therefore does not have a "training set."
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device and therefore does not have a "training set" with established ground truth.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 9, 2022
Careglove Global SDN. BHD. Siti Ahmad Official Correspondent Careglove Global SDN BHD Lot 17479, Lorong Senawang 2/3, Off Jalan Senawang 3, Senewang Industrial Estate Seremban, Negeri Sembilan Darul Khusus 70450 Malaysia
Re: K211666
Trade/Device Name: Powder Free Nitrile Examination Gloves, Blue Chemotest Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: November 25, 2021 Received: December 6, 2021
Dear Siti Ahmad:
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.
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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 of medical device-related adverse events) (21 CFR 803) for 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 mediation-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.
For Clarence W. Murray III, PhD 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)
Device Name
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, CHEMOTEST
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.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Chemotherapy Drugs Permeation The following chemicals have been tested with these gloves.
Chemotherapy Drugs Concentration Breakthrough Detection Time in Minutes *Carmustine (BCNU) 3.3 mg/ml 22.6 Cisplatin Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min Dacarbazine Doxorubicin HCL 2.0 mg/ml >240 min Etoposide 20.0 mg/ml >240 min Fluorouracil 50.0 mg/ml >240 min Ifosfamide 50.0 mg/ml >240 min Mitoxantrone 2 mg/ml >240 min Paclitaxel 6.0 mg/ml >240 min *Thio Tepa 10.0 mg/ml >43.9 Vincristine Sulfate 1.0 mg/ml >240 min
- WARNING: Not recommended for use with Carmustine and Thlotepa. Please note that following drugs have extremely low permeation times: Carmustine (BCNU): 22.6 minutes and Thiotepa: 43.9 munites
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(K) SUMMARY K211666
CAREGLOVE GLOBAL SDN BHD Applicant:
- Location Lot 17479, Lorong Senawang 2/3 Off Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia.
Phone No. (60) 6 6782377 Fax No. (60) 6 6785377
Contact Person: Lim Kwee Shyan
Summary Preparation Date: 5th January, 2021
Device Information
Trade Name:POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, CHEMOTEST Common Name:POWDER FREE NITRILE EXAMINATION GLOVES Classification Name: Patient Examination Gloves Product Code: LZA, LZC Regulation: 21 CFR 880.6250
Predicate Device Identification
510(k) Number: K162858, Device Name: Careplus Powder Free Nitrile Examination Glove, Blue, Chemotest
Device Description
It is the powder-free variation of the class I latex patient examination gloves made by on-line polymer-coating and mild on-line chlorination process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder.
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.
Comparison of technological characteristics between the predicate and subject devices.
The Powder Free Nitrile Examination Gloves – Blue, Chemotest, are summarized with the following technological characteristic compared to ASTM D6319 or equivalent standards.
| Characteristic | Standard | Specification | Subject DevicePowder Free NitrileExaminationGloves, Blue,Chemotest)K211666 | Predicate Device(Careplus PowderFree NitrileExamination Glove,Blue, Chemotest)K162858 | Remarks |
|---|---|---|---|---|---|
| Product Code | - | - | LZA, LZC | LZA, LZC | Same |
| Intended Use | - | - | Intended for medicalpurposes that is worn onthe examiner's hand toprevent contamination | Intended for medicalpurposes that is wornon the examiner's handto prevent | Same |
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| between patient andexaminer | contamination betweenpatient and examiner | ||||
|---|---|---|---|---|---|
| Design | - | - | Powder Free, Non-Sterile, Ambidextrous,Beaded Cuff | Powder Free, Non-Sterile, Ambidextrous,Beaded Cuff | Same |
| Indications forUse | - | - | A patient examinationglove is a disposabledevice intended formedical purposes that isworn on the examiner'shand to preventcontamination betweenpatient and examiner | A patient examinationglove is a disposabledevice intended formedical purposes thatis worn on theexaminer's hand toprevent contaminationbetween patient andexaminer | Same |
| Construction | - | - | Ambidextrous, PolymerCoated or Chlorinated,Powder Free Nitrile | Ambidextrous, PolymerCoated or Chlorinated,Powder Free Nitrile | Same |
| ColorDescription | - | - | Blue | Blue | Similar |
| Material | - | - | Nitrile | Nitrile | Same |
| Single Use | - | - | Yes | Yes | Same |
| Packaging | - | - | Packed in DispenserBoxes | Packed in DispenserBoxes | Same |
| Chemo DrugsClaim | - | - | Chemo Claim | Chemo Claim | Same |
Summary of non-clinical performance test result
| Characteristic | Standard | Specification | Subject DevicePowder Free NitrileExaminationGloves, Blue,Chemotest)K211666 | Predicate Device(Careplus PowderFree NitrileExaminationGlove, Blue,Chemotest)K162858 | Remarks |
|---|---|---|---|---|---|
| Dimension | ASTMD6319-19 | Same | |||
| Length (size: XSmall), mmLength (size: Small), mmLength (size: Medium), mmLength (size: Large), mmLength (size: XLarge), mm | 220 min220 min230 min230 min230 min | Meet 220mm minMeet 220mm minMeet 230mm minMeet 230mm minMeet 230mm min | Meet 220mm minMeet 220mm minMeet 230mm minMeet 230mm minMeet 230mm min | ||
| Thickness (palm), mmThickness (finger), mm | 0.05 min0.05 min | Meet 0.05mm minMeet 0.05mm min | Meet 0.05mm minMeet 0.05mm min | ||
| Width (size: XSmall), mmWidth (size: Small), mmWidth (size: Medium), mmWidth (size: Large), mmWidth (size: XLarge), mm | 70 ± 1080 ± 1095 ± 10110 ± 10120 ± 10 | Meet 70 ± 10 mmMeet 80 ± 10 mmMeet 95 ± 10 mmMeet 110 ± 10 mmMeet 120 ± 10 mm | Meet 70 ± 10 mmMeet 80 ± 10 mmMeet 95 ± 10 mmMeet 110 ± 10 mmMeet 120 ± 10 mm | ||
| Physical Properties | ASTMD6319-19 | Similar | |||
| (Before Ageing)i) Tensile Strength (MPa)ii) Ultimate Elongation (%) | Min. 14Min. 500 | Meet 14MPa min.Meet 500% min | Meet 14MPa min.Meet 500% min | ||
| (After Aging)i) Tensile Strength (MPa)ii) Ultimate Elongation (%) | Min. 14Min. 400 | Meets 14MPa minMeet 400% min. | Meets 14MPa minMeet 400% min. | ||
| Water Leak Test,1000 mlBefore Aging, AQLAfter Aging, AQL | ASTMD6319-19ASTMD5151-19 | G- I, AQL 2.5(FDA GII, AQL2.5) | Meet AQL 1.5Meet AQL 2.5 | Meet AQL 1.5Meet AQL 2.5 | Similar |
| Powder Free ResidueASTMD6319-19Powder Free Residue,ASTMmg/gloveD6124-06 | Max. 2mg/glove | Meet 2mg/glove max. | Meet 2mg/glove max | Similar | |
| Biocompatibility Testi) Primary Skin IrritationTest | ISO 10993-10 | No IrritationAnimal | i) Primary SkinIrritation Test.Conclusion: Under theconditions of this studythe test material didnot cause an irritantresponse | i)Primary SkinIrritation Test.Conclusion: Underthe conditions of thisstudy the testmaterial did notcause an irritantresponse. | Same |
| ii)Skin SensitizationTest | ISO 10993-10 | No IrritationAnimal | ii)Dermal SensitizationTest.Conclusion: Under theconditions of thisstudy, the test materialdid not produce a skinsensitization effect | ii)DermalSensitizationTest.Conclusion: Underthe conditions of thisstudy, the testmaterial did notproduce a skinsensitization effect. | Same |
| iii) In Vitro CytotoxicityTest | ISO 10993-5:2009 | - | iii) In Vitro CytotoxicityTest.Conclusion: Undercondition of this study,test material exhibitedmoderate cytotoxicityreactivity at 6.0 cm²/mLextract concentrationsand no cytotoxicityreactivity at the 3.0cm²/mL extractconcentrations of thetest. | iii) No data available | Different |
| Iv) Acute Systemic Toxicity | ISO 10993-11 | - | iv) Acute SystemicToxicity.Conclusion: Undercondition of this study,the test materialshowed no adversebiological reaction afteradministration of thesample's extract on therats during the periodof the study. | No data available | Different |
| Chemotherapy DrugPermeation Claim | ASTMD6978-05 | - | Carmustine (BCNU)(3.3 mg/ml) - 22.6,Cisplatin (1.0 mg/ml) ->240 minCyclophosphamide(Cytoxan) (20.0 mg/ml) | Carmustine (BCNU)(3.3 mg/ml) — 10.2minCisplatin (1.0 mg/ml)- >240 min,Cyclophosphamide | Similar |
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| - >240 minDacarbazine (10 mg/ml) - >240 minDoxorubicin HCL (2.0 mg/ml) - >240 minEtoposide (20 mg/ml) - >240 minFlurouracil (50 mg/ml) - >240 minIfosfamide (50.0 mg/ml) - >240 minMitoxantrone (2 mg/ml) - >240 minPaclitaxel (6.0 mg/ml) - >240 minThioTepa (10.0 mg/ml) - 43.9Vincristine Sulfate (1.0 mg/ml) - >240 min | (Cytoxan) (20mg/ml) - >240 minDacarbazine (10.0 mg/ml) - >240 minDoxorubicin HCL (2.0 mg/ml) - >240 minEtoposide (20.0 mg/ml) - >240 minFlurouracil (50.0 mg/ml) - >240 minIfosfamide (50 mg/ml) - >240 min,Mitoxantrone (2.0 mg/ml) - >240 minPaclitaxel (6.0 mg/ml) - >240 minThioTepa (10.0 mg/ml) - >40.5 minVincristine Sulfate (1.0 mg/ml) - >240 min | |
|---|---|---|
| -- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Following is a table showing the actual measured parameters of the gloves (e.g. length, thickness, width, physical properties, etc.) as compare to ASTM. All data meets the standard reference requirement.
| Test | Standard | Acceptance Criteria | Result | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Freedom FromHoles | ASTM D6319-19ASTM D5151-19 | Meet requirement inspection level G-I, AQL 2.5 | Pass | ||||||||||||||||||||||||
| Dimension | ASTM D6319-19 | Size XSmall Small Medium Large XLarge Length, min.mm 220 230 Thickness, min. mm 0.05 Width, ± 10mm 70 80 95 110 120 | Pass | ||||||||||||||||||||||||
| PhysicalProperties | ASTM D6319-19 | Before Aging After Accelerated Aging TensileStrength UltimateElongation TensileStrength UltimateElongation 14 MPa min. 500 % min. 14 MPa min. 400 % min. | Pass | ||||||||||||||||||||||||
| ResidualPowder Content | ASTM D6319-19ASTM D6124-06 | Not more than 2 mg per glove | Pass |
Summary of Clinical Testing
Not applicable
Conclusions:
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K211666, the Powder Free Nitrile Examination Glove Blue Chemotest is a safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K162858.
§ 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.