(118 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Two subject devices are bundled into this 510(k) submission. The subject devices, the Nitrile Powder Free Examination Gloves and the Chemotherapy Nitrile Powder Free Examination Gloves, are single use, disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The gloves are made of nitrile rubber, powder free, ambidextrous with beaded cuff and tested for use with chemotherapy drugs. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that facilitates the user in donning the gloves without using lubricant and donning powder on the glove surface. These gloves are offered in six sizes (XS, S, M, L, XL, XXL), and supplied in non-sterile state. The two subject devices proposed are identical in terms of sizes, materials, color, specification, and process. The only difference between the two is the chemotherapy drug labeling.
The provided document is a 510(k) summary for Nitrile Powder Free Examination Gloves and Chemotherapy Nitrile Powder Free Examination Gloves. It details the non-clinical tests performed to demonstrate substantial equivalence to a predicate device.
Crucially, this document is for a Class I medical device (gloves) and explicitly states that "Clinical data is not required for marketing clearance of patient examination gloves." Therefore, there are no acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance related to an AI/ML device as none of this applies to the product described.
Instead, the document focuses on demonstrating that the gloves meet established performance standards for physical properties, barrier integrity, and biocompatibility.
Here's an analysis based on the information provided, specifically highlighting why the requested AI/ML-related information is absent and what was evaluated:
1. A table of acceptance criteria and the reported device performance
The document provides tables of non-clinical tests and their requirements, which serve as the acceptance criteria for these physical and chemical properties.
| Acceptance Criteria (Standard & Test) | Reported Device Performance (Summary) |
|---|---|
| ASTM D5151 Watertight Test (Freedom from Holes) | Pass Inspection Level G1, AQL 2.5 |
| ASTM D6319 Dimensions | Met requirements for Length (XS: min 220mm, S: min 220mm, M: min 230mm, L: min 230mm, XL: min 230mm, XXL: min 230mm); Palm Width (XS: 70 ± 10mm, S: 80 ± 10mm, M: 95 ± 10mm, L: 110 ± 10mm, XL: 120 ± 10mm, XXL: 130 ± 10mm); Thickness (Finger: min 0.05mm, Palm: min 0.05mm) |
| ASTM D6319 Physical Properties (Before Aging) | Tensile strength: min 14MPa; Ultimate elongation: min 500% |
| ASTM D6319 Physical Properties (After Aging) | Tensile strength: min 14MPa; Ultimate elongation: min 400% |
| ASTM D6124 Powder Amount | Residual powder < 2.0mg/glove |
| ASTM D6978 Chemotherapy Drugs Permeation Test (for Chemotherapy gloves) | Met acceptance criteria for 11 drugs. Specific breakthrough times are listed (e.g., Carmustine (BCNU) 3.3 mg/ml: 32.9 min; Cisplatin 1.0mg/ml: >240 min, etc.). |
| ISO 10993-10 Biological Evaluation (Irritation and Skin Sensitization) | Passed primary skin irritation test and dermal sensitization test (Conclusion: Not an irritant and not a skin sensitizer). |
| ISO 10993-11 Biological Evaluation (Systemic Toxicity) | Passed systemic toxicity test (Conclusion: Considered non-toxic). |
2. Sample sizes used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each specific non-clinical test (e.g., how many gloves were tested for watertightness, or how many samples for biocompatibility). The tests are standardized (ASTM, ISO), meaning they have established sample size requirements for their methodologies, but the specific numbers are not presented in this summary.
Data provenance: The tests were performed by the manufacturer (KL-Kepong Rubber Products Sdn. Bhd. in Malaysia) or accredited labs they contracted. The data is prospective, generated specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device; therefore, there is no "ground truth" to be established by experts in the context of clinical interpretation or diagnosis. The ground truth for these device properties is based on adherence to established international (ISO) and national (ASTM) standards and laboratory testing protocols.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no subjective interpretation or diagnostic outcome to adjudicate for this type of device. The tests are objective and quantitative measurements against predefined specifications.
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 is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is objective and defined by established industry and regulatory standards for physical properties (e.g., dimensional measurements, tensile strength, elongation, freedom from holes, residual powder) and chemical resistance/biocompatibility via standardized testing protocols (e.g., ASTM D6978 for chemotherapy drug permeation, ISO 10993 for biocompatibility).
8. The sample size for the training set
Not applicable. This is not an AI/ML device; there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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May 12, 2022
KL-Kepong Rubber Products SDN. BHD. % Kewin Tham Official Correspondent mdi Consultants, Inc. 55 Northern Blvd. Suite 200 Great Neck, New York 11021
Re: K220118
Trade/Device Name: Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I. reserved Product Code: LZA, LZC Dated: April 6, 2022 Received: April 11, 2022
Dear Kewin Tham:
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 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,
Bifeng Qian, M.D., Ph.D. Acting 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) K220118
Device Name Nitrile Powder Free Examination Gloves
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
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)
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510(k) SUMMARY
K220118
Date Summary Prepared: 12 May 2022
1. Submitter's Identification:
KL-KEPONG RUBBER PRODUCTS SDN. BHD. Lot 134905, ¾ Mile Off Jalan Bercham, Kawasan Perindustrian Bercham, 31400 Ipoh, Perak, Malaysia
Contact: Michael Ng Seng Chuenq Tel: +605-5417337
2. Name of the Devices:
Name of Device Candidate #1: Nitrile Powder Free Examination Gloves
Name of Device Candidate #2:
Chemotherapy Nitrile Powder Free Examination Gloves
3. Regulatory Information:
For Device Candidate #1:
Requlation Name: Regulatory Class: Product Code: Regulation Number: Panel:
Polymer Patient Examination Glove Class I LZA 21 CFR 880.6250 General Hospital
For Device Candidate #2:
Requlation Name: Regulatory Class: Product Code: Regulation Number: Panel:
Patient Examination Glove, Specialty Class I LZC 21 CFR 880.6250 General Hospital
4. Predicate Device Information:
For both Device Candidate #1 and Device Candidate #2:
Predicate Device: K182851
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| Trade/Device Name: | SkyBreeze Zero Nitrile Powder-Free Exam Gloves Testedfor Use with Chemotherapy Drugs |
|---|---|
| Device Classification Name: | Patient Examination Glove |
| Device Class: | Class I |
| Product Code: | LZA, LZC |
| Applicant Name: | O&M Halyard, Inc. |
5. Device Description:
Two subject devices are bundled into this 510(k) submission. The subject devices, the Nitrile Powder Free Examination Gloves and the Chemotherapy Nitrile Powder Free Examination Gloves, are single use, disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. The gloves are made of nitrile rubber, powder free, ambidextrous with beaded cuff and tested for use with chemotherapy drugs. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that facilitates the user in donning the gloves without using lubricant and donning powder on the glove surface. These qloves are offered in six sizes (XS, S, M, L, XL, XXL), and supplied in non-sterile state.
The two subject devices proposed are identical in terms of sizes, materials, color, specification, and process. The only difference between the two is the chemotherapy druq labeling.
6. Indications for Use:
1. Device Candidate #1: Nitrile Powder Free Examination Gloves
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
-
- Device Candidate #2: Chemotherapy Nitrile Powder Free Examination Gloves
A patient examination qlove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs as per ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:
- Device Candidate #2: Chemotherapy Nitrile Powder Free Examination Gloves
Carmustine (BCNU) 3.3 mg/ml: no breakthrough up to 32.9 minutes Cisplatin 1.0mg/ml: no breakthrough up to 240 minutes Cyclophosphamide (Cytoxan) 20.0mg/ml: no breakthrough up to 240 minutes Dacarbazine 10.0mg/ml: no breakthrough up to 240 minutes Doxorubicin HCl 2.0mq/ml: no breakthrough up to 240 minutes Etoposide 20.0mg/ml: no breakthrough up to 240 minutes Fluorouracil 50.0mg/ml: no breakthrough up to 240 minutes Ifosfamide 50.0mg/ml: no breakthrough up to 240 minutes Methotrexate 25.0mg/ml: no breakthrough up to 240 minutes
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Mitomycin C 0.5mg/ml: no breakthrough up to 240 minutes Paclitaxel 6.0mg/ml: no breakthrough up to 240 minutes ThioTepa 10.0mg/ml: no breakthrough up to 35.7 minutes Vincristine Sulfate 1.0mg/ml: no breakthrough up to 240 minutes
Not recommended for use: Carmustine (BCNU) 3.3mg/ml, ThioTepa 10.0mg/ml
7. Comparison to the 510(k) Cleared Devices (Predicate Devices):
| COMPARISONCRITERIA | Subject Device | Predicate Device(K182851) | COMPARISONRESULTS |
|---|---|---|---|
| Manufacturer | KL-Kepong RubberProducts Sdn. Bhd. | O&M Halyard, Inc. | N/A |
| Device ClassificationName/ RegulationNumber | Patient ExaminationGlove/ 21 CFR Part880.6250 | Patient ExaminationGlove/ 21 CFR Part880.6250 | Similar |
| Product Code | LZA, LZC | LZA, LZC | Similar |
| Intended Use /Indications for Use | A patient examinationglove is a disposabledevice intended formedical purposes thatis worn on theexaminer's hand toprevent contaminationbetween patient andexaminer. Thesegloves were tested foruse withchemotherapy drugsas per ASTM D6978-05 (2019) StandardPractice forAssessment ofResistance of MedicalGloves to Permeationby ChemotherapyDrugs. | The SkyBreeze ZeroNitrile Powder-FreeExam Glove is adisposable deviceintended for medicalpurposes that is wornon the examiner's handto preventcontamination betweenpatient and examiner.These gloves weretested for use withchemotherapy drugslisted on the label | Similar |
| Material | Nitrile | Nitrile | Similar |
| Powdered or powderfree | Powder free | Powder free | Similar |
| Single use | Yes | Yes | Similar |
| Sterility | Non-sterile | Non-sterile | Similar |
| Dimensions | Meet requirements ofASTM D6319 | Meet requirements ofASTM D6319 | Similar |
| Physical properties | Meet requirements of | Meet requirements of | Similar |
| ASTM D6319 | ASTM D6319 | ||
| Freedom from Holes | Meet requirements ofASTM D5151 | Meet requirements ofASTM D5151 | Similar |
| Residual Powder | Meet requirements ofASTM D6124 | Meet requirements ofASTM D6124 | Similar |
| Chemotherapy DrugsPermeation Test as perASTM D6978, minimumbreakthrough detectiontime in minutes (forDevice Candidate #2) | Meets acceptancecriteria for 11 drugs | Meets acceptancecriteria for 10 drugs | Minimum 9 drugsmeetingacceptancecriteria.Similar |
| Carmustine (BCNU),3.3 mg/ml: 32.9 | Carmustine (BCNU),3.3 mg/ml: 18.6 | <240, same | |
| Cisplatin, 1.0mg/ml:>240 | Cisplatin, 1.0mg/ml:>240 | Same | |
| Cyclophosphamide(Cytoxan), 20.0mg/ml:>240 | Cyclophosphamide(Cytoxan), 20.0mg/ml:>240 | Same | |
| Dacarbazine,10.0mg/ml: >240 | Dacarbazine,10.0mg/ml: >240 | Same | |
| Doxorubicin HCI,2.0mg/ml: >240 | Doxorubicin HCI,2.0mg/ml: >240 | Same | |
| Etoposide, 20.0mg/ml:>240 | Etoposide, 20.0mg/ml:>240 | Same | |
| Fluorouracil,50.0mg/ml: >240 | Fluorouracil,50.0mg/ml: >240 | Same | |
| Ifosfamide,50.0mg/ml: >240 | Ifosfamide, 50.0mg/ml:>240 | Same | |
| Methotrexate,25.0mg/ml: >240 | Methotrexate,25.0mg/ml: Not tested | Additional test forsubject device | |
| Mitomycin C,0.5mg/ml: >240 | Mitomycin C, 0.5mg/ml:Not tested | Additional test forsubject device | |
| Paclitaxel, 6.0mg/ml:>240 | Paclitaxel, 6.0mg/ml:>240 | Same | |
| ThioTepa, 10.0mg/ml:35.7 | ThioTepa, 10.0mg/ml:48.3 | <240, same | |
| Vincristine Sulfate,1.0mg/ml: >240 | Vincristine Sulfate,1.0mg/ml: >240 | Same | |
| Mitoxantrone,2.0mg/ml: Not tested | Mitoxantrone,2.0mg/ml: >240 | Not to be claimed | |
| BiocompatibilityISO 10993-10Biological Evaluationof Medical Devices -Part 10: Tests forIrritation and SkinSensitization | Under the conditionsof the study, not anirritant and not a skinsensitizer | Under the conditions ofthe study, not primaryskin irritant;Under the conditions ofthe study, not a contactsensitizer | Similar |
| BiocompatibilityISO 10993-11Biological Evaluation ofMedical Devices- Part11: Tests for SystemicToxicity | Under the conditionsof the study, the testarticle is considerednon-toxic | The test article wasconsidered non-toxic | Similar |
Table 1: Comparison to Predicate Device for both Device Candidate #1 and Device Candidate #2:
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8. Summary of Non-Clinical Tests Performed for Determination of Substantial Equivalence for both Device Candidate #1 and Device Candidate #2 are as follows:
| Table 2: Summary Non-Clinical Tests | ||
|---|---|---|
| Standard | Testing | Requirements are met |
| ASTMD5151 | Watertight Test(Freedom fromHoles) | Pass Inspection Level G1, AQL 2.5 |
| ASTMD6319 | Dimensions | LengthXS: min 220mmS: min 220mmM: min 230mmL: min 230mmXL: min 230mmXXL: min 230mmPalm WidthXS: 70 ± 10mmS: 80 ± 10mmM: 95 ± 10mmL: 110 ± 10mmXL: 120 ± 10mmXXL: 130 ± 10mmThicknessFinger: min 0.05mmPalm: min 0.05mm |
| ASTM | Physical | Before Aging: |
Table 2: Summary Non-Clinical Tests
T
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| D6319 | Properties | Tensile strength: min 14MPaUltimate elongation: min 500% |
|---|---|---|
| After Aging:Tensile strength: min 14MPaUltimate elongation: min 400% | ||
| ASTMD6124 | Powder Amount | Residual powder <2.0mg/glove |
| ASTMD6978 | ChemotherapyDrugsPermeation Test | An assessment is made based on thepermeation (breakthrough) of 11chemotherapy drugs through theglove material over a certain period oftime (See Table 1) |
Table 3: Summary of Biocompatibility Tests
| ISO10993-10 | BiologicalEvaluation onMedical Devices-Part 10: Test forIrritation and SkinSensitization | Pass primary skin irritation test anddermal sensitization test |
|---|---|---|
| ISO10993-11 | BiologicalEvaluation ofMedical Devices-Part 11: Tests forSystemic Toxicity | Pass systemic toxicity test |
The following National and International Standards were utilized for testing the subject device:
| ASTM D6319-19 | Standard Specification for Nitrile ExaminationGloves for Medical Application |
|---|---|
| ASTM D5151-19 | Standard Test Method for detection of Holes inMedical Gloves |
| ASTM D6124-06 | Standard Test Method for Residual Powder onMedical Gloves |
| ASTM D6978-05 | Standard Practice for Assessment of Resistance ofMedical Gloves to Permeation by ChemotherapyDrugs |
| ISO 10993-10 | Biological Evaluation on Medical Devices- Part 10:Test for Irritation and Skin Sensitization |
| ISO 10993-11 | Biological Evaluation of Medical Devices- Part 11:Tests for Systemic Toxicity |
None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our
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conclusion that Nitrile Powder Free Examination Gloves/Chemotherapy Nitrile Powder Free Examination Gloves tested met all relevant requirements of the aforementioned tests.
9. Summary of Clinical Tests Performed for both Device Candidate #1 and Device Candidate #2:
Not applicable. Clinical data is not required for marketing clearance of patient examination gloves.
10. Conclusions for both Device Candidate #1 and Device Candidate #2:
The conclusion drawn from the non-Clinical tests demonstrates that the subject devices, the Nitrile Powder Free Examination Gloves and the Chemotherapy Nitrile Powder Free Examination Gloves are as safe, as effective, and perform as well as or better than the legally marketed predicate device cleared under K182851.
§ 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.