STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE

K171093 · Sanrea Healthcare Products Pvt, Ltd. · LZA · Jul 19, 2017 · General Hospital

Device Facts

• Record ID: K171093
• Device Name: STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE
• Applicant: Sanrea Healthcare Products Pvt, Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Jul 19, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended 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

Device Story

Disposable, sterile, powder-free, blue nitrile examination glove; ambidextrous design. Used in clinical settings by healthcare examiners to provide a protective barrier between patient and examiner. Device functions as a physical barrier to prevent contamination. No electronic, software, or algorithmic components.

Clinical Evidence

Bench testing only. Performance verified against ASTM D6319-10, ASTM D5151-06, ASTM D412-06, and ASTM D6124-06. Biocompatibility testing per ISO 10993-10 confirmed non-irritant and non-sensitizing. Sterility validated per ISO 11135-2014 and ISO 11737-2.

Technological Characteristics

Material: Synthetic nitrile latex compound. Form factor: Ambidextrous, blue, powder-free, sterile. Standards: ASTM D6319-10, ASTM D5151-06, ASTM D412-06, ASTM D6124-06, ISO 10993-10, ISO 11135-2014, ISO 11737-2. Sterilization: Ethylene Oxide. No software or electronic components.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner.

Regulatory Classification

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.

Predicate Devices

• Sterile Nitrile Powder free Examination Glove (VBLU) (K132006)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 &<br>Textile Park, Kanjikode, Palakkad<br>Kerala, India– 678 621 |
| 1.3 Telephone | : | + 91-491 -2970145 |
| 1.4 Email | : | [e-mail], [e-mail],<br>[e-mail] |
| 1.5 Contact Person | : | Mr. JOSE PAUL M<br>MANAGER 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 &<br>Textile Park, Kanjikode, Palakkad<br>Kerala, India– 678 621 |
| 2.3 Telephone | : | [phone] |
| 2.4 Email | : | [e-mail], [e-mail],<br>[e-mail] |
| 2.5 Contact Person | : | Mr. JOSE PAUL M<br>MANAGER QA & RA |

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#### PREPARATION DATE 3.0

#### 4.0 NAME OF THE DEVICE

| 4.1 Device Name | : | STERILE NITRILE PATIENT EXAMINATION<br>GLOVES, POWDER FREE, BLUE COLOUR |
|--------------------|---|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 4.2 Trade Name | : | * SANCARE STERILE NITRILE PATIENT EXAMINATION<br>GLOVES POWDER FREE. BLUE COLOUR<br>* GLOVTEK STERILE NITRILE PATIENT EXAMINATION<br>GLOVES 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,<br>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 Nitrile<br>patient examination<br>gloves, Powder free,<br>Blue color |
|---------------------|----------------------------------|-------------------------------------------------------------------------------------|
| Freedom from Holes | ASTM D6319-10 / ASTM<br>D5151-06 | Meets |
| Dimensions | ASTM D6319-10 | Meets |
| Physical Properties | ASTM D6319-10 / ASTM<br>D412-06 | Meets |

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| Powder free residue | ASTM D6319-10 | Meets |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Bio-compatibility | Primary skin irritation<br>ISO 10993-10 | Non-irritant |
| | Skin Sensitization<br>ISO 10993-10 | Non-sensitizer |
| | | |
| Expiration<br>dating/Shelf life | ASTM D7160-05 | Three years |
| | | |
| Sterilization | ISO 11135-2014(E)<br>Sterilization of healthcare<br>products - Ethylene Oxide -<br>Requirements for the<br>development, validation and<br>routiene control of a sterilization<br>process for medical devices | Meets |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| Sterility | ISO 11737 -2<br>Sterilization of Medical devices-<br>Microbiological methods Part 2:<br>Test of sterility performed in the<br>definition , validation and<br>maintenance of sterilization<br>process | 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 /<br>Inspection level / AQL | Sterile, Powder free,<br>Nitrile Examination<br>Gloves- SANCARE | RESULT |
| Freedom from<br>Pin holes | FDA 1000 ml water<br>leak test | ASTM D5151 -06<br>(Reapproved 2011) | ISO 2859-1 /<br>G1/AQL 2.5 | PASS | PASS |
| Dimensions | Length | ASTM D6319 -10 | ISO 2859-1 /<br>S2/AQL 4.0 | > 230 mm | PASS |
| | Width | ASTM D6319 -10 | ISO 2859-1 /<br>S2/AQL 4.0 | 70±10 mm to<br>120±10 mm | PASS |

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| | | | | (sizes XS to XL) | |
|------------------------|-------------------------------|-------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------------|------|
| Physical<br>properties | Thickness | ASTM D6319 -10 | ISO 2859-1 /<br>S2/AQL 4.0 | > 0.05 mm<br>(palm & finger) | PASS |
| | Before aging | ASTM D6319 -10<br>and ASTM D412-06 | ISO 2859-1 /<br>S2/AQL 4.0 | Tensile strength :<br>> 14 Mpa<br>Ultimate Elongation<br>: >500% | PASS |
| | After<br>Accelerated<br>aging | ASTM D6319 -10<br>and ASTM D412-06 | ISO 2859-1 /<br>S2/AQL 4.0 | Tensile strength :<br>> 14 Mpa<br>Ultimate Elongation<br>: > 400 % | PASS |
| Powder free<br>residue | Powder free<br>residue | ASTM D6319 -10<br>and ASTM D6124-06 | N=5 | Less than 2 mg per<br>glove | PASS |
| | Primary skin<br>irritation | ISO 10993 -10 | Under the conditions of the study<br>the device is not an irritant | | PASS |
| Biocompatibility | Skin<br>Sensitization | ISO 10993 -10 | Under the conditions of the study<br>the 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) :<br>K132006 | SUBJECT DEVICE :<br>K171093 | Acceptance<br>criteria/Standard |
|-----------------|------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Manufacturer | HARTALEGA SDN BHD, #<br>7, Kawasan, Perusahaan<br>Suria,<br>Batang Berjuntai, Selangor,<br>Darul Ehsan, MY 45600 | SANREA HEALTHCARE<br>PRODUCTS PVT LTD. Plot #<br>P-56, Pearl Road, Kinfra<br>Integrated Industrial & Textile<br>Park, Kanjikode, Palakkad,<br>Kerala, India – 678 621 | - |

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| Product Name | Sterile Nitrile Powder free | Sterile Nitrile Patient | Patient examination |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Examination Glove(VBLU) | Examination Gloves, Powder<br>free, 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 for<br>XS size to 120 mm for XL<br>size, thickness in finger and<br>palm has a minimum 0.05 mm | 6319-10<br>- Overall length min<br>240 mm, width<br>varies from 70 mm<br>for XS size to 120<br>mm for XL size,<br>thickness in finger<br>and palm has a<br>minimum 0.05 mm |
| Tensile Strength | Meets ASTM D 6319-10 | Tensile strength 14 Mpa min<br>for before aging and 14 Mpa<br>min for after aging<br>Aging done at 70 ±2 deg C<br>for 166±2 hrs or 100±2deg C<br>for 22±0.3 hrs | Meets ASTM D<br>6319-10- Tensile<br>strength 14 Mpa min<br>for before aging and<br>14 Mpa min for after<br>aging |
| Ultimate<br>Elongation | Meets ASTM D 6319-10 | Ultimate elongation 500 %<br>min for before aging and 400<br>% min for after aging. Aging<br>done at 70 ±2 deg C for<br>166±2 hrs or 100±2deg C for<br>22±0.3 hrs | Meets ASTM D<br>6319-10 - Ultimate<br>elongation 500 %<br>min for before aging<br>and 400 % min for<br>after aging. Aging<br>done at 70 ±2 deg C<br>for 166±2 hrs or<br>100±2deg C for<br>22±0.3 hrs |
| Freedom from<br>pinholes | Meets ASTM D 5151 -06<br>and ASTM D6319-10 | Meets ASTM D 5151 -06<br>(2011) and ASTM D6319-10 | ASTM D 5151 -06<br>(2011) and ASTM<br>D6319-10 |
| Residual Powder | Meets ASTM D 6124-06 | Less than 2 mg per glove | ASTM D 6124-<br>06(2011) : Less than<br>2 mg per glove |
| Biocompatibility<br>Tests | Non-irritant -Primary Skin<br>Irritation In Rabbits | Under the conditions of the<br>study the device is not an<br>irritant | Under the conditions<br>of the study the<br>device is not an<br>irritant |
| ISO 10993-10 | Non-sensitizer - skin<br>Sensitization in Guinea pigs | Under the conditions of the<br>study the device is not a<br>sensitizer | Under the conditions<br>of the study the<br>device is not a<br>sensitizer |
| Sterility | Sterile | Sterile | Meets ISO 11737-02 |
| Labeling | * Powder free,<br>* Nitrile patient exam glove<br>* Sterile<br>* Single use only<br>* Ambidextrous<br>* Blue color<br>* Manufactured for<br>* Lot No<br>* Intended use<br>* Quantity<br>* Country of origin | * Powder free,<br>* Nitrile Patient exam glove<br>* Sterile<br>* Single use only<br>* Ambidextrous<br>* Blue color<br>* Manufactured for<br>* Lot No<br>* Intended use<br>* Quantity<br>* Country of origin | Chapter 4 - Labeling<br>- Medical Glove<br>Guidance 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.