(127 days)
Blue Nitrile Examination Gloves Powder Free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.
This document is a 510(k) summary for a medical device (Blue Nitrile Examination Glove Powder Free), demonstrating its substantial equivalence to a predicate device. This type of submission generally relies on non-clinical performance data rather than clinical studies for novel AI/ML devices. Therefore, a direct application of the typical "acceptance criteria" and "study that proves the device meets the acceptance criteria" for AI/ML performance (e.g., accuracy, sensitivity, specificity, MRMC studies) is not present here.
However, we can frame the information provided within the context of the requested questions by translating the device's technical specifications and performance data into a pseudo-"acceptance criteria" and "proof of meeting criteria."
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
For a physical device like a medical glove, "acceptance criteria" relate to its physical and biocompatibility properties, and "performance" refers to the test results demonstrating compliance with these standards.
| Characteristic | Standard/Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimensions | ASTM D6319-10 (Reapproved 2015) | Length Min 230 mm; Width depends on size (e.g., Medium: 95+/-10mm) | Meets/Exceeds (e.g., Length Min 230mm, Medium Width 92mm) |
| Physical Properties | ASTM D6319-10 (Reapproved 2015) | Before Aging: Tensile Strength min 14 Mpa, Ultimate Elongation Min 500%After Aging: Tensile Strength min 14 Mpa, Ultimate Elongation Min 400% | Meets/Exceeds (e.g., Before Aging: 18.62Mpa, 694%; After Aging: 17.68Mpa, 668% for Medium) |
| Thickness | ASTM D6319-10 (Reapproved 2015) | Palm min 0.05 mm, Finger min 0.05 mm | Meets/Exceeds (e.g., Palm 0.09mm, Finger 0.15mm for all sizes) |
| Powder Residue | ASTM D6319-10 / ASTM D6124-06 | ≤2 mg/glove | Meets (e.g., 0.22 mg/glove for Medium) |
| Water Tightness (Holes) | ASTM D5151-06 (Reapproved 2015) | Passes AQL-1.5 | Passes AQL 1.5 |
| Biocompatibility: | |||
| Primary Skin Irritation | ISO 10993-10:2010(E) | Not an irritant | Not an irritant |
| Dermal Sensitization | ISO 10993-10:2010(E) | Not a sensitizer | Not a sensitizer |
| In vitro cytotoxicity | ISO 10993-5:2009(E) | Non-cytotoxic | Cytotoxic (This is a discrepancy or a nuance to be explored within biocompatibility, as the acceptance criteria states "non cytotoxic" but result states "cytotoxic." Often, a cytotoxic result in vitro requires further in vivo investigation, but for gloves, the overall safety profile is considered.) |
| Acute Systemic Toxicity | ISO 10993-11:2017(E) | Extracts do not pose a systemic toxicity concern | Extracts do not pose a systemic toxicity concern |
| Material Mediated Pyrogenicity | ISO 10993-11:2017(E) / USP 41<151> | Non-pyrogenic | Non-pyrogenic |
| Bacterial Endotoxin | USP 42<85> | NMT 20 EU/pair of gloves | <20 EU/pair of gloves |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not explicitly state the specific numerical sample size for each test. Instead, it references conformity to ASTM and ISO standards, which typically prescribe statistical sampling plans. For instance, AQL (Acceptable Quality Level) 1.5 for water tightness implies a specific sampling size based on lot size, but the exact count isn't given.
- Data Provenance: The device is manufactured by Aspen Glove Sdn. Bhd. in Malaysia. The testing was presumably conducted by the manufacturer or a certified lab. The provenance of the "data" itself is from laboratory tests performed on the physical glove product. The data is retrospective in the sense that the testing was completed before the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable in the context of this device. "Ground truth" from expert readers (like radiologists) is relevant for AI-powered diagnostic devices interpreting medical images. For a physical device like a glove, the "ground truth" is established by adherence to globally recognized consensus standards (ASTM, ISO, USP) and the results of laboratory tests performed according to validated methods. The "experts" involved are the scientists and technicians who perform these standardized tests and the regulatory bodies who define the standards.
4. Adjudication method for the test set
- Not applicable. Adjudication methods (e.g., 2+1, 3+1 consensus) are used to establish ground truth in studies where human interpretation is subjective or requires consensus (e.g., AI in radiology). For a physical product's performance characteristics, the "adjudication" is inherently built into the standardized test methods, where results are measured objectively against defined criteria.
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. MRMC studies are designed for evaluating AI in diagnostic imaging by comparing human performance with and without AI assistance. This document describes a medical glove, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This question pertains to the performance of an AI algorithm in isolation. The document describes a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device is based on established consensus standards and objective laboratory measurements (e.g., dimensions, tensile strength measured by equipment, chemical analysis for powder residue, standardized biological assays for biocompatibility). There is no "expert consensus" in the sense of physicians or pathologists interpreting findings, but rather adherence to scientifically defined parameters and test methodologies.
8. The sample size for the training set
- Not applicable. As this is a physical medical device and not an AI/ML algorithm, there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. Similar to point 8, there is no training set or corresponding ground truth establishment process for a physical device.
In summary: This FDA 510(k) submission for a medical glove demonstrates substantial equivalence primarily through non-clinical testing against established physical and biocompatibility standards. The framework requested (acceptance criteria, study design, expert involvement, etc.) is most appropriate for AI/ML-driven diagnostic or therapeutic devices, rather than traditional Class I or II physical medical devices where performance is assessed through standardized laboratory tests.
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September 16, 2021
Aspen Glove Sdn. Bhd. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, Illinois 60504
Re: K211479
Trade/Device Name: Blue Nitrile Examination Glove Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: August 16, 2021 Received: August 16, 2021
Dear Manoj Zacharias:
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 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, 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) K211479
Device Name
Blue Nitrile Examination Glove Powder Free
Indications for Use (Describe)
Blue Nitrile Examination Gloves Powder Free is disposable device intended for medical purpose 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)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY K211479 As required by: 21CFR§807.92(c)
A. APPLICANT INFORMATION
| 510(K) Owner's Name | Aspen Glove Sdn. Bhd. |
|---|---|
| Address | Aspen House, 300, JLN Macalister,10450 Georgetown, Pulau Pinang,Malaysia |
| Phone | +604- 227 5000 |
| Fax | +604- 227 5000 |
| corporate@aspen.com.my | |
| Contact Person | Mr. Iskandar Basha bin Abdul Kadir |
| Designation | Managing Director |
| Contact Number | 017-550 0577 |
| Contact Email | Iskandar@aspenglove.com.my |
| Date Submitted | 16 September 2021 |
B. DEVICE IDENTIFICATION
| Name of the device | Blue Nitrile Examination Glove Powder Free |
|---|---|
| Product proprietary or trade name | AspenMed+ |
| Common or usual name | Exam Gloves |
| Classification name | Patient Examination Gloves |
| Device Classification | Class-I |
| Product Code | LZA |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |
C. PREDICATE DEVICE
| Predicate Device | JR Engineering & Medical Technologies (M) SDN.BHD |
|---|---|
| 510( K) Number | K192333 |
| Regulatory Class | I |
| Product code | LZA |
D. DESCRIPTION OF THEDEVICE:
Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.
E. INTENDED USE OF THE DEVICE:
Blue Nitrile Examination Gloves Powder Free is disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
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F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
| Characteristics | Standards | Device Performance | Remarks | |
|---|---|---|---|---|
| Predicate | Subject | |||
| 510(K) Number | K192333 | K211479 | --- | |
| Name of device | JR MEDIC Blue NitrileExamination GlovesPowder-free | Blue NitrileExamination GlovesPowder Free | --- | |
| Dimensions | ASTMD6319-10(Reapproved 2015) | Length Min 230 m WidthMin 95+/-10mm(for medium size) | Length Min 230 mmWidth Min 95+/-10mm(for medium size) | Same |
| Physical Properties | ASTMD6319-10(Reapproved 2015) | Before AgingTensile Strengthmin 14 MpaUltimate ElongationMin 500%After AgingTensile Strengthmin 14 MpaUltimate ElongationMin 400% | Before AgingTensile Strength min14 MpaUltimate ElongationMin 500%After AgingTensile Strengthmin 14 MpaUltimate ElongationMin 400% | Same |
| Thickness | ASTMD6319-10(Reapproved 2015) | Palm min 0.05 mmFinger min 0.05 mm | Palm min 0.05 mmFinger min 0.05 mm | Same |
| Powder Residue | ASTMD6319-10 | ≤2 mg/glove | ≤2 mg/glove | Similar |
| Biocompatibility | Primary SkinIrritation-ISO 10993-10:2010(E) | Under the condition ofstudy not an irritant | Under the conditionof study not anirritant | Same |
| DermalSensitization- ISO10993-10:2010( E) | Under the conditions ofthe study not a sensitizer | Under the conditionsof the study not asensitizer | Same | |
| In vitro cytotoxicityISO10993-5:2009(E) | Under the conditionsof the study, cytotoxic | Under the conditionsof the study,cytotoxic | Same | |
| Acute SystemicToxicity Test ISO10993-11:2017(E) | Under the conditionsof study the deviceextracts do not pose asystemic toxicity concern | Under the conditionsof study the deviceextracts do not pose asystemic toxicityconcern | Same | |
| Material MediatedPyrogenicity ISO10993-11:2017(E) /USP 41<151> | Under the conditions ofthe study non pyrogenic | Under the conditionsof the study nonpyrogenic | Same | |
| Bacterial Endotoxintest USP 42<85> | No data available | <20EU/pair of gloves | --- | |
| Characteristics | Standards | Device Performance | Remarks | |
| PredicateK192333 | CurrentK211479 | |||
| Water Tight (1000 ml) | ASTM D5151-06 | Passes AQL-1.5 | Passes AQL-1.5 | Similar |
| Intended use | JR MEDIC Blue NitrileExamination GlovesPowder-free isdisposable devicesintended for medicalpurpose that are won onthe examiner's hand toprevent contaminationbetween patient andexaminer. | Blue NitrileExamination GlovesPowder free isdisposable devicesintended for medicalpurpose that are wonon the examiner'shand to preventcontaminationbetween patient andexaminer. | Similar | |
| Material | ASTMD 6319-10(Reapproved2015) | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Same | |
| Texture | Finger Texture | Finger Texture | Same | |
| Size | ASTMD 6319-10(Reapproved2015) | Extra Small, Small,Medium, Large, ExtraLarge | Extra Small, Small,Medium, Large, ExtraLarge | Same |
| Single Use | Medical GloveGuidance Manual- Labeling | Single Use | Single Use | Same |
| Manufacturer(s) | JR Engineering &MedicalTechnologies(M) SDN.BHD.Malaysia | Aspen Glove Sdn. Bhd.Malaysia | ----- |
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There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods. Both devices meet the ASTM standard D6319-10(Reapproved 2015).
NON-CLINICAL TESTING SUMMARY PERFORMANCE DATA
Result Test Method Purpose Acceptance Criteria ASTM D6319-10 (Reapproved To determine the Min 230 mm for all sizes X-Small:- 245 mm 2015) Standard Specification length of the gloves Small:-245 mm for Nitrile Examination Gloves Medium:- 246 mm for Medical Application Large:-248 mm X-Large:- 248 mm ASTM D6319-10 (Reapproved To determine X-small:- 70+/-10 mm X-small-68 mm the 2015) Standard Specification width of the gloves Small:-80+/-10 mm Small:-80 mm Medium:- 95+/-10mm for Nitrile Examination Gloves Medium:- 92 mm 105 mm for Medical Application Large: -110+/−10 mm Large:-X-Large:- 120+/-10 mm X-Large:- 115 mm
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| Test Method | Purpose | AcceptanceCriteria | Result | ||
|---|---|---|---|---|---|
| ASTM D6319-10 (Reapproved2015) Standard Specificationfor Nitrile Examination Glovesfor Medical Application | To determine thethickness of thegloves | Palm 0.05 mm minFinger 0.05 mm minfor all sizes | SizeX-SmallSmallMediumLargeX-Large | Palm0.09mm0.09mm0.09mm0.09mm0.09mm | Finger0.15mm0.15mm0.15mm0.15mm0.15mm |
| ASTM D6319-10 (Reapproved2015) Standard Specificationfor Nitrile Examination Glovesfor Medical Application | To Determine thephysical properties-Tensile strength | Before AgeingTensile Strength14Mpa Min for allsizesAfter AgeingTensile Strength14Mpa Min for allsizes | SizeX-SmallSmallMediumLargeX-Large | Beforeageing18.45Mpa18.54Mpa18.62Mpa18.67Mpa18.72Mpa | Afterageing17.54Mpa17.56Mpa17.68Mpa17.75Mpa17.80Mpa |
| ASTM D6319-10 (Reapproved2015) Standard Specificationfor Nitrile Examination Glovesfor Medical Application | To Determine thephysical properties-Ultimate Elongation | Before AgeingUltimate Elongation500% Min for allsizesAfter AgeingUltimateElongation 400%Min for all sizes | SizeX-SmallSmallMediumLargeX-Large | Beforeageing686%690%694%702%705% | Afterageing659%665%668%670%674% |
| Test Method | Purpose | AcceptanceCriteria | Result | |
|---|---|---|---|---|
| ASTM D5151-06 (Reapproved2015) Standard Test Methodfor Detection of Holes inMedical Gloves | To determine theholes in the gloves | AQL 1.5 | Gloves Passes AQL 1.5 | |
| ASTM D6124-06 (Reapproved2017) Standard Test Methodfor Residual Powder onMedical Gloves | To determine theresidual powder inthe gloves | 2 Mg/Glove Max | SizeX-smallSmallMediumLargeX-Large | Residual PowderContent0.21mg/glove0.21mg/glove0.22 mg/glove0.22 mg/glove0.22 mg/glove |
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BIO-COMPATIBILITY DATA
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ISO 10993-10 BiologicalEvaluation of Medical DevicesTest for Irritation and SkinSensitization. Test done forirritation. | To determine the potential ofthe material under test toproduce dermal irritation inRabbits | Under the conditionof study not anirritant | Under the condition ofstudy not an irritant |
| ISO 10993-10 BiologicalEvaluation of Medical DevicesTest for Irritation and SkinSensitization. Test done Skinsensitization. | To determine the skinsensitization potential of thematerial both in terms ofinduction and elicitation inGuinea Pig. | Under theconditions of thestudy not asensitizer | Under the conditions ofthe study not asensitizer |
| ISO 10993-5:2009 biologicalevaluation of medical devices -part 5, tests for in vitrocytotoxicity. | To evaluate the in vitrocytotoxic potential of the testitem (both inner and outersurface) Extracts in L-929mouse fibroblasts cells usingelution method. | Under theconditions of studynon cytotoxic | Under the conditions ofthe study cytotoxic. |
| ISO 10993-11:2017 biologicalevaluation of medical devices -part 11, tests for systemictoxicity. | To determine the acutesystemic toxicity potential ofthe test item extracts (bothinside and outer surfaces) inSwiss Albino mice. | Under theconditions of studythe device extractsdo not pose asystemic toxicityconcern | Under the conditionsof study the deviceextracts do not pose asystemic toxicityconcern |
| Material MediatedPyrogenicity ISO 10993-11:2017(E) / USP 41<151> | To determine the pyrogenicpotential of the test itemextract following intravenousinjection in New Zealandwhite Rabbits. | Under theconditions of thestudy, the devicedid notdemonstrate amaterial mediatedpyrogenicityresponse. | Under the conditions ofthe study, the device didnot demonstrate amaterial mediatedpyrogenicity response. |
| Bacterial Endotoxin testUSP 42<85> | To determine the BacterialEndotoxin limit in the glove | NMT 20 EU/pair ofgloves | <20 EU/pair of gloves |
G. Clinical Testing Summary
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(K) process.
H. CONCLUSION
The conclusions drawn from the non clinical test demonstrate that the subject device in 510(K) submission, Blue Nitrile Examination Gloves Powder Free is as safe, as effective, and performs as well as or better than the legally marketed predicate device K192333.
§ 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.