(496 days)
The Nitrile Patient Examination gloves. Powderfree. Blue color, is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner
The subject device is a patient examination glove made of synthetic nitrile latex compound. It is non-sterile, powderfree and is Blue in color. The device is ambidextrous and can be worn on either the left or right hand. The device meets ASTM 06319-10: Standard specification for Nitrile Examination Gloves for Medical Application. The subject device is substantially equivalent to legally marketed Nitrile examination gloves identified as Product code LZA.
The device is for over-the counter single use.
The provided document is a 510(k) premarket notification for Nitrile Patient Examination gloves. It does not describe an AI/ML medical device. Therefore, it is not possible to extract information related to AI/ML device acceptance criteria or studies proving device performance, as the requested fields (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth establishment, training set size) are not applicable to this type of medical device submission.
The document focuses on demonstrating substantial equivalence to a predicate device (K121947) through performance data based on established ASTM standards and biocompatibility tests for examination gloves.
Here's the relevant information that directly addresses the "acceptance criteria and the study that proves the device meets the acceptance criteria" for this non-AI/ML medical device:
1. A table of acceptance criteria and the reported device performance:
The document provides a detailed table comparing the subject device (Nitrile Patient Examination gloves, Powderfree, Blue color) to a legally marketed predicate device (ETS Blue Powderfree Nitrile patient exam glove, K121947) across various characteristics. The "Acceptance criteria/Standard" column outlines the benchmarks, typically ASTM standards or FDA guidance. The "SUBJECT DEVICE : K143477" column indicates the subject device's performance against these criteria, consistently stating "PASS" or meeting the specified physical properties.
| Characteristics | Acceptance Criteria/Standard | Reported Device Performance (Nitrile Patient Examination gloves, Powderfree, Blue color) |
|---|---|---|
| Freedom from Holes | ASTM D6319-10 / ASTM D5151-06 (FDA 1000 ml water leak test, ISO 2859-1 / G11 AQL 2.5) | Meets / PASS |
| Dimensions | ASTM D6319-10 (ISO 2859-1 / S2 AQL 4.0) - Length: min 230 mm (> 240-400mm met); Width: 70±10 mm to 120±10 mm (sizes XS to XL met); Thickness: > 0.05 mm (palm & finger met) | PASS |
| Physical Properties | Before aging: ASTM D6319-10 and ASTM D412-06 (ISO 2859-1 / S2 AQL 4.0) - Tensile strength: > 14 Mpa; Ultimate Elongation: > 500%After accelerated aging: ASTM D6319-10 and ASTM D412-06 (ISO 2859-1 / S2 AQL 4.0) - Tensile strength: > 14 Mpa; Ultimate Elongation: > 400% | PASS (Tensile strength: > 14 Mpa, Ultimate Elongation: > 500% before aging; Tensile strength: > 14 Mpa, Ultimate Elongation: > 400% after accelerated aging) |
| Powder-free residue | ASTM D6319-10 / ASTM D6124-06 (N=5) - Less than 2 mg per glove | Meets / PASS (Less than 2 mg per glove) |
| Biocompatibility | ISO 10993-10 - Primary skin irritation (non-irritant); Skin/Dermal Sensitization (non-sensitizer) | Non-irritant; Non-sensitizer |
| Expiration dating/Shelf life | ASTM D7160-05 | Three years |
| Intended Use | Medical Glove Guidance Manual (Intended for medical purpose to prevent contamination between patient and examiner) | Meets |
| Indication for Use | Medical Glove Guidance Manual (Disposable device for medical purposes, worn on hand/finger to prevent contamination) | Meets |
| Material | ASTM D6319-10, LZA product code (Nitrile synthetic latex) | Meets (Nitrile synthetic latex) |
| Non-sterile or sterile | Sterility (Non Sterile) | Non Sterile |
| Single Use | Disposable/Single use | Yes |
| Ambidextrous | ASTM D6319-0 | Yes |
2. Sample sized used for the test set and the data provenance:
The document refers to sampling plans and inspection levels for certain tests:
- Freedom from Pin holes: ISO 2859-1 / G11 AQL 2.5
- Dimensions: ISO 2859-1 / S2 AQL 4.0
- Physical Properties (Before and After aging): ISO 2859-1 / S2 AQL 4.0
- Powder-free residue: N=5 gloves
The exact numerical sample sizes for each test are not explicitly stated as absolute numbers but rather by the sampling plans (e.g., ISO 2859-1). The data provenance is not explicitly mentioned as "country of origin" for the test data, nor is it categorized as "retrospective or prospective." However, given the nature of the device (examination gloves) and the standards used, it's implied that these are laboratory tests performed on samples of the manufactured gloves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This is a non-AI/ML medical device submitting for 510(k) clearance. The "ground truth" for the physical and chemical properties of the gloves is established through adherence to defined ASTM and ISO standards and laboratory testing protocols, not by expert consensus or interpretations in a diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as this is not an AI/ML device involving human interpretation that would require an adjudication method.
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 a non-AI/ML medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a non-AI/ML medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is based on established industry standards and validated laboratory test methods. This includes:
- ASTM International Standards: Such as ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application), ASTM D5151-06 (Standard Test Method for Detection of Holes in Medical Gloves), ASTM D412-06 (Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension), ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves), and ASTM D7160-05 (Standard Practice for Determination of Expiration Dating for Medical Gloves).
- ISO Standards: Specifically ISO 10993-10 (Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization) for biocompatibility.
- FDA water leak test (1000ml).
8. The sample size for the training set:
Not applicable. This is a non-AI/ML medical device; therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this non-AI/ML medical device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing right, with a wing-like shape above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2016
Primus Gloves PVT Limited Jose Paul M Manager-QA & RA Plot No: 14-A, Cochin Special Economic Zone Kakkanad, Cochin, Kerala 682037 INDIA
Re: K143477
Trade/Device Name: Nitrile Patient Examination gloves, Powderfree, Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: undated Received: April 12, 2016
Dear Mr. Jose Paul M:
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. 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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K143477
Device Name
Nitrile Patient Examination gloves, Powderfree, Blue color
Indications for Use (Describe)
The Nitrile Patient Examination gloves. Powderfree. Blue color, is a disposable device intended for medical purposes that is worn on the examiners' hand or finger 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 RE
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ATTACHMENT V
K143477
| 1.0 | SUBMITTER | |||||
|---|---|---|---|---|---|---|
| 1.1 | Company Name | PRIMUS GLOVES PRIVATE LIMITED | ||||
| 1.2 | Address | Plot No: 14-A, Cochin Special Economic Zone, | ||||
| Kakkanad, Cochin, Kerala, India - 682037 | ||||||
| 1.3 | Telephone | + 91 484 2413063 | ||||
| 1.4 | Fax | +91 484 2413089 | ||||
| 1.5 | josegaul@grimusgloves.com | |||||
| 1.6 | Contact Person | Mr. JOSE PAUL M | ||||
| MANAGER-QA & RA | ||||||
| 2.0 | OFFICIAL CORRESPONDENT | |||||
| 2.1 | Company Name | PRIMUS GLOVES PRIVATE LIMITED | ||||
| 2.2 | Address | Plot No: 14-A, Cochin Special Economic Zone, | ||||
| Kakkanad, Cochin, Kerala, India - 682037 | ||||||
| 2.3 | Telephone | + 91 484 2413063 | ||||
| 2.4 | Fax | +91 484 2413089 | ||||
| 2.5 | josegaul@grimusgloves.com | |||||
| 2.6 | Contact Person | Mr. JOSE PAUL M | ||||
| MANAGER-QA & RA | ||||||
| 3.0 | Preparation date | 14th April, 2016 | ||||
| 4.0 | Name of the device | |||||
| 4.1 | Device Name | NITRILE PATIENT EXAMINATION | ||||
| GLOVES, POWDERFREE, BLUE COLOR | ||||||
| 4.2 | Trade Name | PRIMUS NITRILE EXAMINATION GLOVES | ||||
| 4.3 | Common Name | PATIENT EXAMINATION GLOVES | ||||
| 4.4 | Classification | 21 CFR 880.6250 PATIENT EXAMINATION GLOVES | ||||
| 4.5 | Class | CLASS I |
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- 4.6 Product code LZA
5.0 ldentification of the leqally marketed predicate device
| 5.1 | Device Name | ETS Blue Powderfree Nitrile patient examglove |
|---|---|---|
| 5.2 | 510(k) Number | K121947 |
| 5.3 | Company | Northstar Healthcare Holdings, 70 Sir JohnRogerson's Quay, Dublin 2, Ireland. |
| 5.4 | Device Description | Non sterile Nitrile powderfree exam gloves |
| 5.5 | Classification | PATIENT EXAMINATION GLOVES |
| 5.6 | Class | CLASS I |
| 5.7 | Product code | LZA |
| 5.8 | Classification Panel : | General Hospital |
Description of the Device 6.0
The subject device is a patient examination glove made of synthetic nitrile latex compound. It is non-sterile, powderfree and is Blue in color. The device is ambidextrous and can be worn on either the left or right hand. The device meets ASTM 06319-10: Standard specification for Nitrile Examination Gloves for Medical Application. The subject device is substantially equivalent to legally marketed Nitrile examination gloves identified as Product code LZA.
The device is for over-the counter single use.
7.0 Indications for use
The Nitrile Patient Examination gloves, Powderfree, Blue color, is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.
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8.0 Summary of performance data
There is no difference in technological characteristics compared to the predicate device. Gloves are made from Nitrile latex compound, Non sterile, Powderfree and Blue in color. The gloves have the same technological characteristics compared to ASTM or equivalent standards as given below,
| Characteristics | Standards | Performance of Nitrilepatient examinationgloves, Powderfree, Bluecolor |
|---|---|---|
| Freedom from Holes | ASTM 06319-10 / ASTM05151-06 | Meets |
| Dimensions | ASTM D6319-10 | Meets |
| Physical Properties | ASTM D6319-10 / ASTM0412-06 | Meets |
| Powder-free residue | ASTM 06319-10 | Meets |
| Bio-compatibility | Primary skin irritationISO 10993-10 | Non-irritant |
| Skin/Dermal SensitizationISO 10993-10 | Non-sensitizer | |
| Expiration dating/Shelf life | ASTM D7160-05 | Three years |
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Performance data of gloves based on ASTM 06319-10 and FDA 1000ml water leak test
| ASTM 06319-10 and FDA 1000 ml water leak test | |||||
|---|---|---|---|---|---|
| Characteristics | Test | Test standard | Sampling plan/Inspection level/AQL | Non sterile, powderfree, Non sterile Nitrile examination gloves-PRIMUS | RESULT |
| Freedom from Pin holes | FDA 1000 ml water leak test | ASTM D5151-06 (reap 2011) | ISO 2859-1 / G11AQL 2.5 | PASS | PASS |
| Dimensions | Length | ASTM D6319-10 | ISO 2859-1 / S21AQL 4.0 | > 230 mm ( 240-400mm) | PASS |
| Width | ASTM D6319-10 | ISO 2859-1 / S21AQL 4.0 | 70±10 mm to 120±10 mm (sizes XS to XL) | PASS | |
| Thickness | ASTM D6319-10 | ISO 2859-1 / S21AQL 4.0 | > 0.05 mm (palm & finger) | PASS | |
| Physical properties | Before aging | ASTM D6319-10 and ASTM D412-06 | ISO 2859-1 / S21AQL 4.0 | Tensile strength : > 14 MpaUltimate Elongation : > 500% | PASS |
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| strength :> 14 Mpa | |||||
|---|---|---|---|---|---|
| AfterAcceleratedaging | ASTM06319-10and ASTM0412-06 | ISO 2859-1 /S2/AQL 4.0 | UltimateElongation :> 400 % | PASS | |
| Powder-freeresidue | Powder-freeresidue | ASTMD6319-10and ASTM06124-06 | N=5 | Less than 2mg per glove | PASS |
| Biocompatibility | Primary skinirritation | ISO10993-10 | Under the conditions of thestudy the device is not anirritant | PASS | |
| Skin/DermalSensitization | ISO10993-10 | Under the conditions of thestudy the device is not asensitizer | PASS |
9.0 Summary of the technological characteristics of device compared to the legally marketed predicate device
| Characteristics | PREDICATE-510(K) :K121947 | SUBJECT DEVICE :K143477 | Acceptancecriteria/Standard |
|---|---|---|---|
| Manufacturer | NorthstarHealthcareHoldings, 70 SirJohnRogerson'sQuay, Dublin 2,Ireland. | PRIMUS GLOVESPRIVATE LIMITED, PlotNo: 14-A, CSEZ,Kakkanad, Cochin,Kerala, India -682037 | |
| Product Name | ETS BluePowder Free | Nitrile PatientExamination Gloves, | Patientexamination |
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| Nitrile PatientExam Gloves | Powderfree Blue colorgloves | gloves | |
|---|---|---|---|
| Intended Use | Intended formedical purposethat is worn onthe Examinershand to preventcontaminationbetween patientand examiner | Intended for medicalpurpose that is worn onthe Examiners hand toprevent contaminationbetween patient andexaminer | Medical GloveGuidance Manual |
| Indication for use | The examinationgloves is adisposabledevice intendedfor medicalpurposes that isworn on theexaminers handor finger topreventcontaminationbetween patientand examiner | The examination glovesis a disposable deviceintended for medicalpurposes that is worn onthe examiners hand orfinger to preventcontamination betweenpatient and examiner | Medical GloveGuidance Manual |
| Description | Non sterilepowderfree ,examinationgloves made ofnitrile andcolored blue Thetextured gloves | Non sterile powderfree ,examination glovesmade of nitrile andcolored blue Thetextured gloves areprovided in sizes ExtraSmall, Small, Medium, | Medical GloveGuidance Manual |
| are provided insizes ExtraSmall, Small,Medium, ExtraLarge. Thesmooth glovesare provided inSizes Small,Medium, Largeand Extra Large | Extra Large. Thesmooth gloves areprovided in Sizes Small,Medium, Large andExtra Large | ||
| Presentation | Non sterilegloves areprovided indispenser boxes | Non sterile gloves areprovided in dispenserboxes | Medical GloveGuidance Manual |
| Material | Nitrile syntheticlatex | Nitrile synthetic latex | ASTM 06319-10LZA product code |
| Non-sterile orsterile | Non Sterile | Non Sterile | Sterility |
| Single Use | Yes | Yes | Disposable/Singleuse |
| Ambidextrous | Yes | Yes | ASTM D 6319-0 |
| Dimensions | Meets ASTM D6319-10 | Overall length min 240mm ,width varies from70 mm for XS size to120 mm for XL size,thickness in finger andpalm has a minimum0.05 mm | Meets ASTM D6319-10-Overall lengthmin 240 mm,width varies from70 mm for XSsize to 120 mmfor XL size, |
| and palm has a | |||
| minimum 0.05 | |||
| mm | |||
| Tensile strength 14 Mpa | Meets ASTM D | ||
| min for before aging and | 6319-10- Tensile | ||
| 14 Mpa min for after | strength 14 Mpa | ||
| aging | min for before | ||
| Aging done at 70 ±2 deg | aging and 14 Mpa | ||
| C for 166±2 hrs or | min for after | ||
| Tensile Strength | Meets ASTM D | 100±2deg C for 22±0.3 | aging |
| 6319-10 | hrs | Ultimate | |
| elongation 500 % | |||
| min for before | |||
| aging and 400 % | |||
| min for after | |||
| aging. Aging | |||
| done at 70 ±2 | |||
| deg C for 166±2 | |||
| hrs or 100±2deg | |||
| C for 22±0.3 hrs | |||
| Ultimate elongation 500 | Meets ASTM D | ||
| % min for before aging | 6319-10- | ||
| Ultimate | Meets ASTM D | and 400 % min for after | Ultimate |
| Elongation | 6319-10 | aging. Aging done at 70 | elongation 500 % |
| ±2 deg C for 166±2 hrs | min for before | ||
| or 100±2deg C for | aging and 400% | ||
| 22±0.3 hrs | min for after | ||
| aging. Aging | |||
| done at 70 ±2 | |||
| deg C for 166±2hrs or 100±2degC for 22±0.3 hrs | |||
| Freedom frompinholes | Meets ASTM D5151 -06 andASTM 06319-10 | Meets ASTM D 5151 -06 (2011) and ASTM06319-10 | ASTM D 5151 -06(2011) and ASTM06319-10 |
| Residual Powder | Meets ASTM D6124-06 | Less than 2 mg perglove | ASTM O 6124-06(2011) : Lessthan 2 mg perglove |
| BiocompatibilityTestsISO 10993-10 | Non-irritant -Primary SkinIrritation InRabbitsNon-sensitizer -skin Sensitizationin Guinea pigs | Under the conditions ofthe study the device isnot an irritantUnder the conditions ofthe study the device isnot a sensitizer | Under theconditions of thestudy the deviceis not an irritantUnder theconditions of thestudy the deviceis not a sensitizer |
| Labeling | Powderfree,Nitrile patientexam gloveNon sterileSingle use onlyAmbidextrousBlue colorManufactured forLot NoIntended useQuantityCountry of origin | *Powderfree,*Nitrile Patient examglove*Non sterile*Single use only*Blue color*Ambidextrous*Manufactured for*Lot No*Intended use*Quantity*Country of origin | Chapter 4-Labeling-Medical GloveGuidance Manual |
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10.0 CONCLUSION
The physical performance of the subject device is substantially equivalent to predicate K121947 and will perform according to the glove performance and biocompatibility standards referenced. Based on the intended use, physical properties and technological characteristics, the subject device is as safe, effective and performs as well as the legally marketed predicate device.
§ 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.