(104 days)
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.
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 acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color and are powder free.
The provided information is a 510(k) summary for "Blue Nitrile Examination Gloves Powder Free". This document describes the device and its equivalence to a predicate device, based on non-clinical performance testing. It does not describe a study involving an AI/Machine Learning driven medical device, human readers, or the establishment of ground truth by expert consensus for medical image interpretation or similar.
Therefore, most of the requested information regarding AI/ML device studies (e.g., number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) is not applicable to this document.
However, I can extract the acceptance criteria and reported device performance from the non-clinical testing summary as requested for a physical device:
Acceptance Criteria and Device Performance for Blue Nitrile Examination Gloves Powder Free
This document describes the non-clinical performance of the "Blue Nitrile Examination Gloves Powder Free" and its substantial equivalence to a predicate device (K192333). The study performed is a series of laboratory tests to ensure the physical and chemical properties of the gloves meet established standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-10 (Reapproved 2015) Standard Specification for Nitrile Examination Gloves for Medical Application | To determine the length of the gloves | Min 230 mm for all sizes | X-Small: 305 mmSmall: 305 mmMedium: 305mmLarge: 306mmX-Large: 306mm |
| ASTM D6319-10 (Reapproved 2015) Standard Specification for Nitrile Examination Gloves for Medical Application | To determine the width of the gloves | X-small: 70+/-10 mmSmall: 80+/-10 mmMedium: 95+/-10mmLarge: 110+/-10 mmX-Large: 120+/-10 mm | X-small: 74 mmSmall: 84 mmMedium: 94 mmLarge: 105 mmX-Large: 115 mm |
| ASTM D6319-10 (Reapproved 2015) Standard Specification for Nitrile Examination Gloves for Medical Application | To determine the thickness of the gloves | Palm 0.05 mm minFinger 0.05 mm min for all sizes | PalmX-Small: 0.10mmSmall: 0.10mmMedium: 0.10mmLarge: 0.10mmX-Large: 0.10mmFingerX-Small: 0.13mmSmall: 0.13mmMedium: 0.14mmLarge: 0.13mmX-Large: 0.14mm |
| ASTM D5151-06 (Reapproved 2015) Standard Test Method for Detection of Holes in Medical Gloves | To determine the holes in the gloves | AQL 1.5 | Passes AQL 1.5 |
| ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves | To determine the residual powder in the gloves | 2 Mg/Glove Max | Residual Powder ContentX-Small: 0.21mg/gloveSmall: 0.21mg/gloveMedium: 0.22 mg/gloveLarge: 0.22 mg/gloveX-Large: 0.22 mg/glove |
| ASTM D6319-10 (Reapproved 2015) Standard Specification for Nitrile Examination Gloves for Medical Application | To Determine the physical properties - Tensile strength | Before Ageing: Tensile Strength 14Mpa Minimal for all sizesAfter Ageing: Tensile Strength 14Mpa Minimal for all sizes | Tensile Strength (Mpa)Before AgeingX-Small: 18.43Small: 18.49Medium: 18.54Large: 18.57X-Large: 18.64After AgeingX-Small: 17.49Small: 17.51Medium: 17.65Large: 17.67X-Large: 17.71 |
| ASTM D6319-10 (Reapproved 2015) Standard Specification for Nitrile Examination Gloves for Medical Application | To Determine the physical properties - Ultimate Elongation | Before Ageing: Ultimate Elongation 500% Min for all sizesAfter Ageing: Ultimate Elongation 400% Min for all sizes | Ultimate Elongation (%)Before AgeingX-Small: 685Small: 688Medium: 692Large: 695X-Large: 698After AgeingX-Small: 654Small: 658Medium: 661Large: 665X-Large: 669 |
| Biocompatibility (Primary Skin Irritation - ISO 10993-10:2010(E)) | Biocompatibility | Under the condition of study not an irritant | Under the condition of study not an irritant |
| Biocompatibility (Dermal Sensitization - ISO 10993-10:2010(E)) | Biocompatibility | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer |
| Biocompatibility (In vitro cytotoxicity - ISO10993-5:2009(E)) | Biocompatibility | (Predicate: Under the conditions of the study, cytotoxic) (Subject: Under the conditions of the study, non-cytotoxic) | Under the conditions of the study, non-cytotoxic |
| Biocompatibility (Acute Systemic Toxicity Test ISO 10993-11:2017(E)) | Biocompatibility | Under the condition of study not systemic toxic | Under the conditions of study, the device extracts do not pose a systemic toxicity concern |
| Biocompatibility (Material Mediated Pyrogenicity ISO 10993-11:2017(E) / USP 41<151>) | Biocompatibility | Under the conditions of the study non pyrogenic | Under the conditions of the study non pyrogenic |
| Biocompatibility (Bacterial Endotoxin test USP 42<85>) | Biocompatibility | (Predicate: No data available) (Subject: <20EU/pair of gloves) | <20EU/pair of gloves |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the numerical sample sizes for each test. However, it indicates compliance with ASTM standards, which typically specify sampling plans. The data provenance is implied to be from the manufacturer's internal testing as part of the 510(k) submission process. The manufacturing location is Thailand ("Hi-Care Thai Gloves Co. Ltd. Thailand."). The specific tests are non-clinical, laboratory-based physical and chemical tests, not involving patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This is for a physical device (examination gloves), not an AI/ML medical image analysis device requiring expert radiological review and ground truth establishment.
4. Adjudication Method for the Test Set:
Not applicable. This is for a physical device, not an AI/ML medical image analysis device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is for a physical device.
6. Standalone (Algorithm Only) Performance:
Not applicable. This is for a physical device.
7. Type of Ground Truth Used:
For this physical device, the "ground truth" is defined by the physical and chemical properties of the gloves as measured against established ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards (e.g., ASTM D6319-10 for dimensions, physical properties, thickness; ASTM D5151-06 for water tightness/holes; ASTM D6124-06 for residual powder; ISO 10993 series for biocompatibility; USP for pyrogenicity and bacterial endotoxin).
8. Sample Size for the Training Set:
Not applicable. This is a manufactured physical good, not an AI/ML model.
9. How the Ground Truth for the Training Set was Established:
Not applicable.
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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. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 2, 2020
Hi-Care Thai Gloves Co. Ltd. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, Illinois 60504
Re: K202384
Trade/Device Name: Blue Nitrile Examination Gloves Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA Dated: October 31, 2020 Received: November 3, 2020
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.
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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,
For: CAPT Elizabeth Claverie, M.S. 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) K202384
Device Name Blue Nitrile Examination Gloves Powder Free
Indications for Use (Describe)
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.
| 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 K202384
Prepared following 21CFR §807.92(C)
Hi-Care Thai Gloves Co. Ltd.
A. APPLICANT INFORMATION
510(K) Owner's Name Address
| Address | 199Moo.11, T.Banpru, A.Hatyai, Songkhla 90250Thailand. |
|---|---|
| Phone | +66-92 225 8472 |
| Fax | +66-74-291044 |
| daniel@hicarethai.com | |
| Contact Person | Mr. Daniel John |
| Designation | International Operations Manager, |
| Contact Number | +66-92 225 8472 |
| Contact Email | daniel@hicarethai.com |
| Date 510(K) summary prepared | August 14th, 2020 |
B. DEVICE IDENTIFICATION
| Name of the device | Blue Nitrile Examination Gloves Powder Free |
|---|---|
| Product proprietary or trade name | Palm Care Blue Nitrile Examination Gloves Powder Free |
| Common or usual name | Patient Examination Gloves |
| Classification name | Patient Examination Gloves |
| Device Classification | Class-1 |
| 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 | 1 | |
| Product code | LZA |
D. DESCRIPTION OF THE DEVICE:
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 acrylonitrilebutadiene 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
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | REMARKS | |
|---|---|---|---|---|
| PREDICATE | SUBJECT | |||
| 510(K) Number | K192333 | K202384 | ---- | |
| Name of device | JR MEDIC Blue NitrileExamination GlovesPowder free | Blue NitrileExamination GlovesPowder free | ---- | |
| Dimensions | ASTMD 6319-10(Reapproved 2015) | Length Min 230 mWidth Min 95+/-10mm(for medium size) | Length Min 230 mmWidth Min 95+/mm(for medium size) | Same |
| Physical Properties | ASTMD 6319-10(Reapproved 2015) | Before AgingTensile Strengthmin 14 MpaUltimate ElongationMin 500%After AgingTensile Strengthmin 14 MpaUltimate ElongationMin 400% | Before AgingTensile Strengthmin 14 MpaUltimate ElongationMin 500%After AgingTensile Strengthmin 14 MpaUltimate ElongationMin 400% | Same |
| Thickness | ASTMD 6319-10(Reapproved 2015) | Palm min 0.05 mmFinger min 0.05 mm | Palm min 0.05 mmFinger min 0.05 mm | Same |
| Powder Residue | ASTMD 6319-10 | $\le$ 2 mg/glove | $\le$ 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 conditions ofthe study, cytotoxic | Under the conditionsof the study, non-cytotoxic | different | |
| Acute SystemicToxicity Test ISO10993-11:2017(E) | Under the condition ofstudy not systemic toxic | 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 | ---- | |
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | REMARKS | |
| PREDICATE | CURRENT | |||
| Water Tight (1000 ml) | ASTM D 5151-06 | 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 6910-10(Reapproved2015) | Nitrile (NBR) | Nitrile (NBR) | 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. | Hi-Care Thai GlovesCo. Ltd. Thailand. | ----- |
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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 D6913-10(Reapproved 2015).
G. NON-CLINICAL TESTING SUMMARY
PERFORMANCE DATA
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM D6319-10 (Reapproved2015) Standard Specification forNitrile Examination Gloves forMedical Application | To determine the lengthof the gloves | Min 230 mm for all sizes | X-Small:-305 mmSmall:-305 mmMedium:-305mmLarge:-306mmX-Large:-306mm |
| ASTM D6319-10 (Reapproved2015) Standard Specification forNitrile Examination Gloves forMedical Application | To determine the widthof the gloves | X-small: -70+/-10 mmSmall: -80+/-10 mmMedium: -95+/-10mmLarge: -110+/-10 mmX-Large: -120+/-10 mm | X-small-74 mmSmall: -84 mmMedium: -94 mmLarge: -105 mmX-Large: -115 mm |
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| TEST METHOD | PURPOSE | ACCEPTANCECRITERIA | RESULT | |
|---|---|---|---|---|
| ASTM D6319-10 (Reapproved2015) Standard Specification forNitrile Examination Gloves forMedical Application | To determinethe thicknessof the gloves | Palm 0.05 mm minFinger 0.05 mm min forall sizes | SizeX-SmallSmallMediumLargeX-Large | Palm Finger0.10mm 0.13mm0.10mm 0.13mm0.10mm 0.14mm0.10mm 0.13mm0.10mm 0.14mm |
| ASTM D5151-06 (Reapproved2015) Standard Test Method forDetection of Holes in MedicalGloves | To determinethe holes in thegloves | AQL 1.5 | Gloves Passes AQL 1.5 | |
| ASTM D6124-06 (Reapproved2017) Standard Test Method forResidual Powder on MedicalGloves | To determinethe residualpowder in thegloves | 2 Mg/Glove Max | SizeX-smallSmallMediumLargeX-Large | Residual Powder Content0.21mg/glove0.21mg/glove0.22 mg/glove0.22 mg/glove0.22 mg/glove |
| ASTM D6319-10(Reapproved 2015) StandardSpecification for NitrileExamination Gloves for MedicalApplication | To Determinethe physicalproperties-Tensile strength | Before AgeingTensile Strength 14MpaMinimal for all sizesAfter Ageing TensileStrength 14MpaMinimal for all sizes | SizeX-SmallSmallMediumLargeX-Large | Before Afterageing ageing18.43Mpa 17.49Mpa18.49Mpa 17.51Mpa18.54Mpa 17.65Mpa18.57Mpa 17.67Mpa18.64Mpa 17.71Mpa |
| To Determinethe physicalproperties-UltimateElongation | Before AgeingUltimate Elongation500% Min for all sizesAfter Ageing UltimateElongation 400% Minfor all sizes | SizeX-SmallSmallMediumLargeX-Large | Before Afterageing ageing685% 654%688% 658%692% 661%695% 665%698% 669% |
H. CLINICAL TESTING SUMMARY
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
I. CONCLUSION
The conclusions drawn from the non-clinical test demonstrate that the subject device K202384 in 510(K) submission, Blue Nitrile Examination Gloves Powder Free is 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.