(98 days)
The Sterile Nitrile Patient Examination gloves, Powder free, 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 sterile, Powder free and is Blue in colour. The device is ambidextrous and can be worn on either the left or right hand. The device meets ASTM D6319-10: 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 describes the Sanrea Healthcare Products Pvt Ltd's Sterile Nitrile Patient Examination Gloves, Powder free, Blue color, and its equivalence to a predicate device. The information details the performance testing and acceptance criteria for this Class I medical device.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Test Standard / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Freedom from Holes | ASTM D6319-10 / ASTM D5151-06 (Reapproved 2011) with Sampling plan / Inspection level / AQL: ISO 2859-1 / G1/AQL 2.5; FDA 1000 ml water leak test | Meets / PASS |
| Dimensions: Length | ASTM D6319-10; ISO 2859-1 / S2/AQL 4.0; > 230 mm | Meets / PASS (> 230 mm) |
| Dimensions: Width | ASTM D6319-10; ISO 2859-1 / S2/AQL 4.0; 70±10 mm to 120±10 mm (sizes XS to XL) | Meets / PASS (70±10 mm to 120±10 mm - sizes XS to XL) |
| Physical Properties: Thickness | ASTM D6319-10; ISO 2859-1 / S2/AQL 4.0; > 0.05 mm (palm & finger) | Meets / PASS (> 0.05 mm - palm & finger) |
| Physical Properties: Tensile strength (Before aging) | ASTM D6319-10 and ASTM D412-06; ISO 2859-1 / S2/AQL 4.0; > 14 Mpa | Meets / PASS (> 14 Mpa) |
| Physical Properties: Ultimate Elongation (Before aging) | ASTM D6319-10 and ASTM D412-06; ISO 2859-1 / S2/AQL 4.0; > 500% | Meets / PASS (> 500%) |
| Physical Properties: Tensile strength (After Accelerated Aging) | ASTM D6319-10 and ASTM D412-06; ISO 2859-1 / S2/AQL 4.0; > 14 Mpa (Aging done at 70 ±2 deg C for 166±2 hrs or 100±2deg C for 22±0.3 hrs) | Meets / PASS (> 14 Mpa) |
| Physical Properties: Ultimate Elongation (After Accelerated Aging) | ASTM D6319-10 and ASTM D412-06; ISO 2859-1 / S2/AQL 4.0; > 400% (Aging done at 70 ±2 deg C for 166±2 hrs or 100±2deg C for 22±0.3 hrs) | Meets / PASS (> 400%) |
| Powder-free residue | ASTM D6319-10 and ASTM D6124-06; N=5; Less than 2 mg per glove | Meets / PASS (Less than 2 mg per glove) |
| Biocompatibility: Primary skin irritation | ISO 10993-10; Under the conditions of the study, the device is not an irritant. | Non-irritant / PASS (Under the conditions of the study, the device is not an irritant.) |
| Biocompatibility: Skin Sensitization | ISO 10993-10; Under the conditions of the study, the device is not a sensitizer. | Non-sensitizer / PASS (Under the conditions of the study, the device is not a sensitizer.) |
| Expiration dating/Shelf life | ASTM D7160-05 | Three years |
| Sterilization | ISO 11135-2014(E) (Ethylene Oxide) | Meets |
| Sterility | ISO 11737-2; Test of sterility performed in the definition, validation and maintenance of sterilization process. | Sterile / PASS |
2. Sample size used for the test set and the data provenance
- Sample Size for Physical Properties and Freedom from Holes: The sample sizes are generally cited within the "Sampling plan / Inspection level / AQL" column. For example, for "Freedom from Holes," it refers to "ISO 2859-1 / G1/AQL 2.5." For "Dimensions" and "Physical Properties," it refers to "ISO 2859-1 / S2/AQL 4.0." For "Powder-free residue," N=5 is used. The specific number of gloves tested within these AQL standards is not explicitly stated as a single number but is dictated by the standard.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The manufacturer is SANREA HEALTHCARE PRODUCTS PVT LTD, located in Palakkad, Kerala, India. It can be inferred that the testing was conducted either internally by the manufacturer or by a third-party laboratory, likely in India, to demonstrate compliance with the cited ASTM and ISO standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable to this type of device (patient examination gloves). The "ground truth" for these tests is established by objective physical, chemical, and biological measurements performed according to recognized international standards (ASTM, ISO). There is no interpretation by human experts required to establish a diagnostic ground truth, unlike with image-based AI devices.
4. Adjudication method for the test set
This is not applicable as the tests are objective measurements against defined physical, chemical, and biological criteria, not subjective interpretations requiring adjudication.
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
This is not applicable. This document describes a medical device (examination gloves) that does not incorporate AI or involve human readers for diagnostic interpretation. Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is an inanimate object (nitrile gloves) and does not involve any algorithms.
7. The type of ground truth used
The "ground truth" for the performance claims of these gloves is based on:
- Standardized Physical Measurements: Length, width, thickness, tensile strength, ultimate elongation performed according to ASTM D6319-10 and ASTM D412-06.
- Standardized Chemical Measurements: Powder-free residue performed according to ASTM D6124-06.
- Standardized Biological Testing: Biocompatibility (primary skin irritation and skin sensitization) performed according to ISO 10993-10, and sterility testing according to ISO 11737-2.
- Performance Tests: Freedom from holes measured by FDA 1000 ml water leak test and ASTM D5151-06.
8. The sample size for the training set
This is not applicable. There is no "training set" for this type of medical device as it does not involve machine learning or AI algorithms. The performance is assessed through direct physical, chemical, and biological testing of manufactured samples.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this device.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 19, 2017
Sanrea Healthcare Products Pvt Ltd Jose M. Paul Manager Oa & RA Plot #P-56, Pearl Road Kinfra IIT Park, Kanjikode Palakkad, 678 621 In
Re: K171093
Trade/Device Name: Sterile Nitrile Patient Examination Gloves, Powder free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: July 23, 2017 Received: April 12, 2017
Dear Jose M. Paul:
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
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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 the quality systems (QS) 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,
Tara A. Ryan -S
for Lori Wiggins, MPT, CLT Acting 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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Indications for Use
510(k) Number (if known) K171093
Device Name
STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDER FREE, BLUE COLOUR
Indications for Use (Describe)
The Sterile Nitrile Patient Examination gloves, Powder free, 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)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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1.0 SUBMITTER
| 1.1 Company Name | : | SANREA HEALTHCARE PRODUCTS PVT LTD |
|---|---|---|
| 1.2 Address | : | Plot#P-56, Pearl Road, Kinfra Integrated Industrial &Textile Park, Kanjikode, PalakkadKerala, India– 678 621 |
| 1.3 Telephone | : | + 91-491 -2970145 |
| 1.4 Email | : | josepaul@primusgloves.com, sanreaqa@gmail.com,qa@sanrea.com |
| 1.5 Contact Person | : | Mr. JOSE PAUL MMANAGER QA & RA |
2.0 OFFICIAL CORRESPONDENT
| 2.1 Company Name | : | SANREA HEALTHCARE PRODUCTS PVT LTD |
|---|---|---|
| 2.2 Address | : | Plot#P-56, Pearl Road, Kinfra Integrated Industrial &Textile Park, Kanjikode, PalakkadKerala, India– 678 621 |
| 2.3 Telephone | : | +91-491-2970145 |
| 2.4 Email | : | josepaul@primusgloves.com, sanreaqa@gmail.com,qa@sanrea.com |
| 2.5 Contact Person | : | Mr. JOSE PAUL MMANAGER QA & RA |
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PREPARATION DATE 3.0
4.0 NAME OF THE DEVICE
| 4.1 Device Name | : | STERILE NITRILE PATIENT EXAMINATIONGLOVES, POWDER FREE, BLUE COLOUR |
|---|---|---|
| 4.2 Trade Name | : | * SANCARE STERILE NITRILE PATIENT EXAMINATIONGLOVES POWDER FREE. BLUE COLOUR* GLOVTEK STERILE NITRILE PATIENT EXAMINATIONGLOVES POWDER FREE, BLUE COLOUR |
| 4.3 Common Name | : | PATIENT EXAMINATION GLOVES |
| 4.4 Classification | : | PATIENT EXAMINATION GLOVES |
| 4.5 Class | : | CLASS I |
| 4.6 Product Code | : | LZA |
IDENTIFICATION OF LEGALLY MARKETED PREDICATE DEVICE 5.0
| 5.1 Device Name | : | Sterile Nitrile Powder free Examination Glove (VBLU) |
|---|---|---|
| 5.2 510(k) Number | : | K132006 |
| 5.3 Company | : | HARTALEGA SDN BHD, # 7, Kawasan, Perusahaan Suria,Batang Berjuntai, Selangor, Darul Ehsan, MY 45600 |
| 5.4 Device Description | : | Sterile Nitrile Powder free Examination Glove(VBLU) |
| 5.5 Classification | : | PATIENT EXAMINATION GLOVES |
| 5.6 Class | : | CLASS I |
| 5.7 Product Code | : | LZA |
| 5.8 Classification Panel | : | General Hospital |
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6.0 DESCRIPTION OF THE DEVICE
The subject device is a patient examination glove made of synthetic nitrile latex compound. It is sterile, Powder free and is Blue in colour. The device is ambidextrous and can be worn on either the left or right hand. The device meets ASTM D6319-10: 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 Sterile Nitrile Patient Examination gloves, Powder free., 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.
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, Sterile, Powder free 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, Powder free,Blue color |
|---|---|---|
| Freedom from Holes | ASTM D6319-10 / ASTMD5151-06 | Meets |
| Dimensions | ASTM D6319-10 | Meets |
| Physical Properties | ASTM D6319-10 / ASTMD412-06 | Meets |
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| Powder free residue | ASTM D6319-10 | Meets |
|---|---|---|
| Bio-compatibility | Primary skin irritationISO 10993-10 | Non-irritant |
| Skin SensitizationISO 10993-10 | Non-sensitizer | |
| Expirationdating/Shelf life | ASTM D7160-05 | Three years |
| Sterilization | ISO 11135-2014(E)Sterilization of healthcareproducts - Ethylene Oxide -Requirements for thedevelopment, validation androutiene control of a sterilizationprocess for medical devices | Meets |
| Sterility | ISO 11737 -2Sterilization of Medical devices-Microbiological methods Part 2:Test of sterility performed in thedefinition , validation andmaintenance of sterilizationprocess | Sterile |
Performance data of gloves based on ASTM D6319-10 and FDA 1000ml water leak test
| ASTM D6319-10 and FDA 1000 ml water leak test | |||||
|---|---|---|---|---|---|
| Characteristics | Test | Test standard | Sampling plan /Inspection level / AQL | Sterile, Powder free,Nitrile ExaminationGloves- SANCARE | RESULT |
| Freedom fromPin holes | FDA 1000 ml waterleak test | ASTM D5151 -06(Reapproved 2011) | ISO 2859-1 /G1/AQL 2.5 | PASS | PASS |
| Dimensions | Length | ASTM D6319 -10 | ISO 2859-1 /S2/AQL 4.0 | > 230 mm | PASS |
| Width | ASTM D6319 -10 | ISO 2859-1 /S2/AQL 4.0 | 70±10 mm to120±10 mm | PASS |
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| (sizes XS to XL) | |||||
|---|---|---|---|---|---|
| Physicalproperties | Thickness | ASTM D6319 -10 | ISO 2859-1 /S2/AQL 4.0 | > 0.05 mm(palm & finger) | PASS |
| Before aging | ASTM D6319 -10and ASTM D412-06 | ISO 2859-1 /S2/AQL 4.0 | Tensile strength :> 14 MpaUltimate Elongation: >500% | PASS | |
| AfterAcceleratedaging | ASTM D6319 -10and ASTM D412-06 | ISO 2859-1 /S2/AQL 4.0 | Tensile strength :> 14 MpaUltimate Elongation: > 400 % | PASS | |
| Powder freeresidue | Powder freeresidue | ASTM D6319 -10and ASTM D6124-06 | N=5 | Less than 2 mg perglove | PASS |
| Primary skinirritation | ISO 10993 -10 | Under the conditions of the studythe device is not an irritant | PASS | ||
| Biocompatibility | SkinSensitization | ISO 10993 -10 | Under the conditions of the studythe device is not a sensitizer | PASS | |
| Sterility | Sterility | ISO-11737-2 | Sterile |
9.0 Summary of the technological characteristics of device compared to the legally marketed predicate device
| Characteristics | PREDICATE – 510(K) :K132006 | SUBJECT DEVICE :K171093 | Acceptancecriteria/Standard |
|---|---|---|---|
| Manufacturer | HARTALEGA SDN BHD, #7, Kawasan, PerusahaanSuria,Batang Berjuntai, Selangor,Darul Ehsan, MY 45600 | SANREA HEALTHCAREPRODUCTS PVT LTD. Plot #P-56, Pearl Road, KinfraIntegrated Industrial & TextilePark, Kanjikode, Palakkad,Kerala, India – 678 621 | - |
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| Product Name | Sterile Nitrile Powder free | Sterile Nitrile Patient | Patient examination |
|---|---|---|---|
| Examination Glove(VBLU) | Examination Gloves, Powderfree, Blue color | gloves | |
| Intended Use | Intended for medical purpose | Intended for medical purpose | Medical Glove |
| that is worn on the | that is worn on the Examiners | Guidance Manual | |
| Examiners hand or finger to | hand or finger to prevent | ||
| prevent contamination | contamination between | ||
| between patient and | patient and examiner | ||
| examiner | |||
| Indication for use | The examination gloves is a | The Sterile Nitrile Patient | Medical Glove |
| disposable device intended | Examination gloves, Powder | Guidance Manual | |
| for medical purposes that is | free., Blue color, is a | ||
| worn on the examiners hand | disposable device intended | ||
| or finger to prevent | for medical purposes that is | ||
| contamination between | worn on the examiners' hand | ||
| patient and examiner | or finger to prevent | ||
| contamination between | |||
| patient and examiner. | |||
| Description | Sterile Powder free, | Sterile Powder free , | Medical Glove |
| examination gloves made of | examination gloves made of | Guidance Manual | |
| nitrile and colored blue. The | nitrile and colored blue. The | ||
| gloves are provided in Sizes | gloves are provided in Sizes | ||
| Extra Small, Small, Medium, | Extra Small, Small, Medium, | ||
| Large and Extra Large | Large and Extra Large | ||
| Presentation | Sterile gloves are provided in | Sterile gloves are provided in | Medical Glove |
| pouches | pouches | Guidance Manual | |
| Material | Nitrile synthetic latex | Nitrile synthetic latex | ASTM D6319-10 |
| LZA product code | |||
| Non-sterile or | Sterile | Sterile | Sterility |
| sterile | |||
| Single Use | Yes | Yes | Disposable / |
| Single use | |||
| Ambidextrous | Yes | Yes | ASTM D 6319-0 |
| Overall length min 240 mm | Meets ASTM D | ||
| Dimensions | Meets ASTM D 6319-10 | ,width varies from 70 mm forXS size to 120 mm for XLsize, thickness in finger andpalm has a minimum 0.05 mm | 6319-10- Overall length min240 mm, widthvaries from 70 mmfor XS size to 120mm for XL size,thickness in fingerand palm has aminimum 0.05 mm |
| Tensile Strength | Meets ASTM D 6319-10 | Tensile strength 14 Mpa minfor before aging and 14 Mpamin for after agingAging done at 70 ±2 deg Cfor 166±2 hrs or 100±2deg Cfor 22±0.3 hrs | Meets ASTM D6319-10- Tensilestrength 14 Mpa minfor before aging and14 Mpa min for afteraging |
| UltimateElongation | Meets ASTM D 6319-10 | Ultimate elongation 500 %min for before aging and 400% min for after aging. Agingdone at 70 ±2 deg C for166±2 hrs or 100±2deg C for22±0.3 hrs | Meets ASTM D6319-10 - Ultimateelongation 500 %min for before agingand 400 % min forafter aging. Agingdone at 70 ±2 deg Cfor 166±2 hrs or100±2deg C for22±0.3 hrs |
| Freedom frompinholes | Meets ASTM D 5151 -06and ASTM D6319-10 | Meets ASTM D 5151 -06(2011) and ASTM D6319-10 | ASTM D 5151 -06(2011) and ASTMD6319-10 |
| Residual Powder | Meets ASTM D 6124-06 | Less than 2 mg per glove | ASTM D 6124-06(2011) : Less than2 mg per glove |
| BiocompatibilityTests | Non-irritant -Primary SkinIrritation In Rabbits | Under the conditions of thestudy the device is not anirritant | Under the conditionsof the study thedevice is not anirritant |
| ISO 10993-10 | Non-sensitizer - skinSensitization in Guinea pigs | Under the conditions of thestudy the device is not asensitizer | Under the conditionsof the study thedevice is not asensitizer |
| Sterility | Sterile | Sterile | Meets ISO 11737-02 |
| Labeling | * Powder free,* Nitrile patient exam glove* Sterile* Single use only* Ambidextrous* Blue color* Manufactured for* Lot No* Intended use* Quantity* Country of origin | * Powder free,* Nitrile Patient exam glove* Sterile* Single use only* Ambidextrous* Blue color* Manufactured for* Lot No* Intended use* Quantity* Country of origin | Chapter 4 - Labeling- Medical GloveGuidance Manual |
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10.0 CONCLUSION
The conclusions drawn from the non clinical tests of the subject device K171093(Sterile Nitrile Patient Examination Gloves, Powder free., Blue color) demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device identified as Sterile Nitrile Powder free Examination Glove (VBLU), cleared under K132006.
§ 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.