(234 days)
A non-sterile powder free 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. The device is for over-the-counter use.
The subject device in this 510(k) Notification is Powder Free Nitrile Examination Glove. The subject device is a patient examination glove made from nitrile compound, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets the specifications in ASTM D6319-19, standard specification for Nitrile Examination Gloves.
The provided document is an FDA 510(k) summary for a medical device (Non-sterile Powder Free Nitrile Examination Gloves). It does not describe an AI/ML-driven medical device, nor does it involve image analysis, expert-based ground truth, or MRMC studies. Therefore, many of the requested elements for describing a study proving an AI/ML device meets acceptance criteria are not applicable.
However, I can extract the relevant "acceptance criteria" (performance specifications) and the "study that proves the device meets the acceptance criteria" (non-clinical performance tests) from the document as it pertains to this specific device.
Here's the information based on the provided document:
Device: Non-sterile Powder Free Nitrile Examination Gloves (K210990)
Device Type: Patient Examination Glove (Class I, reserved)
Intended Use: Disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. For over-the-counter use.
1. A table of acceptance criteria and the reported device performance
| Test Item | Test Standard | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|---|
| Dimensions | ASTM D6319-19 | Overall Length (mm): Min 230mmWidth (± 5mm): Size S = 85mm, Size M = 95mm, Size L = 105mm, Size XL = 115mmThickness at Palm (mm): Min 0.05 mmThickness at Finger Tip (mm): Min 0.05 mm | Not explicitly stated with specific values, but declared as "Passed" | Passed |
| Physical properties | ASTM D6319-19 | Before Aging:Tensile Strength (MPa) = 14minUltimate Elongation (%) = 500minAfter Aging at 70°C for 168 hrs @ 100°C for 22 hrs:Tensile Strength (MPa) = 14minUltimate Elongation (%) = 400min | Not explicitly stated with specific values, but declared as "Passed" | Passed |
| Freedom from pinholes | ASTM D6319-19 | AQL 2.5 (Inspection Level G-1) | Not explicitly stated with specific values, but declared as "Passed" | Passed |
| Residual Powder | ASTM D6124-06 (Reapproved 2017) | < 2.0 mg/pc | Not explicitly stated with specific values, but declared as "Passed" | Passed |
| Biocompatibility (Primary Skin Irritation) | ISO 10993-10 | Non-irritant | "test article was a non-irritant." | Similar to Predicate |
| Biocompatibility (Dermal Sensitization Assay) | ISO 10993-10 | Non-sensitizer | "test article was a non-sensitizer." | Similar to Predicate |
| Biocompatibility (Cytotoxicity) | ISO 10993-5 | Not explicitly stated as a numerical criterion, but the predicate did not perform this test. The subject device showed "cytotoxic at 100% after an exposure period of 48 hours, non-cytotoxic at 10%". This difference was addressed by the FDA. | Test found cytotoxic at 100% after 48 hrs, non-cytotoxic at 10%. | Different from Predicate (predicate didn't test) |
| Biocompatibility (Acute Systemic Toxicity) | ISO 10993-11 | Not induce systemic toxicity | "Not induce systemic toxicity" | Similar to Predicate |
2. Sample sized used for the test set and the data provenance
The document refers to standard test methods (e.g., ASTM D6319-19, ASTM D5151-19, ISO 28590:2017 for sampling). These standards specify the sample sizes for tests like AQL inspections for pinholes. For example, ASTM D5151-19, "Standard Test Method for Detection of Holes in Medical Gloves," would define the process for testing pinholes using an AQL (Acceptable Quality Limit) of 2.5. ISO 28590:2017 is explicitly mentioned as a "Sampling Procedure for Inspection by Attributes."
- Sample Size: Not explicitly stated as a single number, but implied to follow the sampling plans within the referenced standards (e.g., AQL 2.5, Inspection Level G-1 for pinholes).
- Data Provenance: The tests are non-clinical (laboratory tests on physical samples/materials). The manufacturer is Rubberex Alliance Sdn Bhd, based in Ipoh, Perak, Malaysia. The testing would have been conducted by the manufacturer or a contracted lab. The data is prospective as it describes the testing performed on the device samples to support the 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 for a physical medical device (gloves), not an AI/ML device that requires expert-established ground truth for image interpretation or similar. The "ground truth" for these tests are objective measurements and compliance with chemical/physical standards.
4. Adjudication method for the test set
Not applicable. See point 3.
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. The "performance" is the physical properties of the glove itself.
7. The type of ground truth used
The "ground truth" is established by:
- Objective Measurement: Adherence to specified dimensions (length, width, thickness), tensile strength, and elongation through standardized testing methods.
- Chemical Analysis: Measurement of residual powder.
- Biological Testing: Standardized in-vitro and in-vivo biocompatibility tests (irritation, sensitization, cytotoxicity, systemic toxicity) as defined by ISO 10993 series.
- Statistical Sampling: AQL (Acceptable Quality Limit) tests for defects like pinholes, using established statistical sampling procedures (ISO 28590:2017).
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 22, 2021
Rubberex Alliance Sdn Bhd % Aristotle Nafpliotis Regulatory Affairs Consultant/Engineer mdi Consultants. Inc. 55 Northern Blvd Great Neck, New York 11021
Re: K210990
Trade/Device Name: Non-sterile Powder Free Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: October 18, 2021 Received: October 19, 2021
Dear Aristotle Nafpliotis:
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
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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,
For 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210990
Device Name
Non-sterile Powder Free Nitrile Examination Gloves
Indications for Use (Describe)
A non-sterile powder free 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. The device is for over-the-counter use.
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
K210990
1. Submitter's Identification:
RUBBEREX ALLIANCE SDN BHD Lot 138201 Off ¾ Mile, Jalan Bercham Kawasan Perindustrian Bercham 31400 Ipoh, Perak, Malaysia
Date Summary Prepared: 17 November 2021
Contact: Sabri Hamid
2. Name of the Device:
Non-sterile Powder Free Nitrile Examination Gloves K#: K210990 Regulation Number: 880.6250 Regulation Name: Polymer Patient Examination Glove Requlatory Class: 1 Product Code: LZA
3. Information for the 510(k) Cleared Device (Predicate Device):
Predicate device: K200326 Trade/Device Name: Powder Free Nitrile Examination Glove (Aqua Green) Device Classification Name: Patient Examination gloves (21 CFR 880.6250) Device Class: Class I Product Code: LZA Applicant name: Riverstone Resources SDN BHD Lot 55, No 13 Jalan Jasmin 2 Kawasan Perindustrian Bukit Beruntung, 48300 My
4. Device Description:
The subject device in this 510(k) Notification is Powder Free Nitrile Examination Glove. The subject device is a patient examination glove made from nitrile compound, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets the specifications in ASTM D6319-19, standard specification for Nitrile Examination Gloves.
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Specifications: Dimension and Thickness of Gloves (ASTM D6319-10)
| Dimension | Size XS | Size S | Size M | Size L | Size XL |
|---|---|---|---|---|---|
| Overall Length (mm) | min 220 | min 220 | min 230 | min 230 | min 230 |
| Width (± 10mm) | 70 | 80 | 95 | 110 | 120 |
| Thickness at Palm(mm) | min 0.05 | min 0.05 | min 0.05 | min 0.05 | min 0.05 |
| Thickness at FingerTip (mm) | min 0.05 | min 0.05 | min 0.05 | min 0.05 | min 0.05 |
| Specifications: Gloves Physical Properties and Holes (ASTM D6319-19) | ||||
|---|---|---|---|---|
| Measurement | Before Aging | After Aging at 70°C for 168hrs @ 100°C for 22 hrs |
|---|---|---|
| Tensile Strength (MPa) | min 14 | min 14 |
| Ultimate Elongation (%) | min 500 | min 400 |
| Pin-hole Level | AQL 2.5Inspection Level G-1 | AQL 2.5Inspection Level G-1 |
5. Indications for Use:
A non-sterile powder free 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. The device is for over-thecounter use.
Technological Gharacteristics Comparison between the predicate and 6. subiect devices:
| Item description | Subject Device,Non-sterile PowderFree NitrileExamination GloveK210990 | Predicate Device,Powder FreeExamination Glove(Aqua green),K200326 | Similar or Different |
|---|---|---|---|
| K Number: | K210990 | K200326 | |
| Product Code | LZA | LZA | Similar |
| Intended use | A powder freepatientexamination gloveis a disposabledevice intended formedical purposesthat is worn on theexaminer's hand orfinger to preventcontaminationbetween patientand examiner. Thedevice is for over-the-counter use. | A powder freepatientexamination gloveis a disposabledevice intended formedical purposesthat is worn on theexaminer's hand orfinger to preventcontaminationbetween patientand examiner. Thedevice is for over-the-counter use. | Similar |
| Material use | Nitrile compound | Nitrile compound | Similar |
| Colour | Blue | Aqua Green | Different |
| Sterility | Non sterile | Non sterile | Similar |
| Single used | Single used | Single used | Similar |
| Dimensions | OverallLength (mm)Min 220mmWidth (±10mm) SizeXS = 70mmS = 80mmSize M=95mm SizeL = 110mmSize XL =120mmThickness atPalm (mm)Min; 0.05mmThickness atFinger Tip(mm) Min0.05 mm | OverallLength (mm)Min 230mmWidth (±5mm) Size S= 85mmSize M=95mm SizeL = 105mmSize XL =115mmThickness atPalm (mm)Min; 0.05mmThickness atFinger Tip(mm) Min0.05 mm | Similar |
| Physical properties | Before AgeingTensile Strength(MPa) = 14minUltimate Elongation(%) = 500min AfterAging at 70 +- 2 oCfor 166 +- 2 hrsTensile Strength(MPa) = 14minUltimate Elongation(%) = 400min | Before AgeingTensile Strength(MPa) = 14minUltimate Elongation(%) = 500min AfterAging at 70oC for168 hrs @ 100oCfor 22 hrs TensileStrength (MPa) =14min UltimateElongation (%) =400min | Similar |
| Freedom frompinholes | AQL 2.5InspectionLevel G-1 | AQL 2.5InspectionLevel G-1 | Similar |
| Residual Powder | < 2.0 mg/pc | < 2.0 mg/pc | Similar |
| BiocompatibilityISO 10993-10-BiologicalEvaluationon Medical Device- Primary SkinIrritation Test | Under theconditions of thisstudy, the testarticle was a non-irritant. | Under theconditions of thisstudy, the testarticle was a non-irritant. | Similar |
| BiocompatibilityISO 10993-10-BiologicalEvaluationon Medical Device- DermalSensitization Assay | Under theconditions of thisstudy, the testarticle was a non-sensitizer. | Under theconditions of thisstudy, the testarticle was a non-sensitizer. | Similar |
| BiocompatibilityISO 10993-5Biologicalevaluation ofmedicaldevices - Part5: Tests for invitrocytotoxicity | Under theconditions of thisstudy, the testwas foundcytotoxic at 100%after an exposureperiod of 48hours, non-cytotoxic at 10% | Predicate did notperform this testas part of thissubmission. | Different |
| BiocompatibilityISO 10993-11-Acute Systemictest | Not inducesystemic toxicity | Not inducesystemic toxicity | Similar |
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Summarv of Non-Clinical Tests Performed 7.
Non-sterile Powder Free Nitrile Examination Glove was tested and found in conformance with the following standards:
| ASTM D6319-19 | Standard Specification for NitrileExamination Gloves for MedicalApplication |
|---|---|
| ASTM D412-16 | Standards test method for VulcanizedRubber and Thermoplastics Elastomer -Tension |
| ASTM D5151-19 | Standard Test Method for detection ofHoles in Medical Gloves |
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| ASTM D6124-06 | Standard Test Method for ResidualPowder on Medical Gloves |
|---|---|
| ISO 10993-5 | Biological evaluation of medical devicesPart 5: Tests for in vitro cytotoxicity |
| ISO 10993-10 | Biological evaluation on medical devicePart 10: Test for irritation and SkinIrritation |
| ISO 10993-11 | Biological evaluation on medical devicePart 11: Test for acute systemic toxicity |
| ISO 28590:2017 | Sampling Procedure for Inspection byAttributes: Introduction to the ISO 2859series of standards for sampling forinspection by attributes. |
Summary of non-clinical performance test
| Test item | Test standard | Acceptance Criteria | Conclusion |
|---|---|---|---|
| Dimensions | ASTM D6319-19 | Overall Length (mm)Min 230mm Width (±5mm) Size S = 85mmSize M= 95mm Size L= 105mm Size XL =115mm Thickness atPalm (mm) Min; 0.05mm Thickness atFinger Tip (mm) Min0.05 mm | Passed |
| Physical properties | ASTM D6319-19 | Before Ageing TensileStrength (MPa) =14min UltimateElongation (%) =500min After Aging at70°C for 168 hrs @100°C for 22 hrsTensile Strength (MPa)= 14min UltimateElongation (%) =400min | Passed |
| Freedom from pinholes | ASTM D6319-19 | AQL 2.5Inspection Level G-1 | Passed |
| Residual Powder | ASTM D6124-06(Reapproved 2017) | < 2.0 mg/pc | Passed |
8. Conclusions:
The Conclusion drawn from the Non-Clinical test demonstrates that the subject device, Non-sterile Powder Free Nitrile Examination Glove is as safe, as effective, and performs as well as or better than the legally marketed Predicate device cleared under K200326.
§ 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.