Nitrile Patient Examination gloves, Powderfree, Blue color

K143477 · Primus Gloves Pvt Limited · LZA · Apr 14, 2016 · General Hospital

Device Facts

• Record ID: K143477
• Device Name: Nitrile Patient Examination gloves, Powderfree, Blue color
• Applicant: Primus Gloves Pvt Limited
• Product Code: LZA · General Hospital
• Decision Date: Apr 14, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended 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

Device Story

Disposable, non-sterile, ambidextrous nitrile synthetic latex examination glove; blue color; powder-free. Used by healthcare examiners to prevent cross-contamination between patient and examiner. Device functions as a physical barrier. No electronic, software, or algorithmic components. Performance verified against ASTM standards for physical properties, dimensions, and freedom from holes.

Clinical Evidence

Bench testing only. No clinical data. Testing included FDA 1000ml water leak test (ASTM D5151-06), physical dimensions, tensile strength/elongation (ASTM D6319-10, D412-06), powder residue (ASTM D6124-06), and biocompatibility (ISO 10993-10 primary skin irritation and dermal sensitization). All results met acceptance criteria.

Technological Characteristics

Material: Nitrile synthetic latex. Form: Non-sterile, powder-free, ambidextrous, blue color. Standards: ASTM D6319-10 (dimensions, physical properties, powder residue), ASTM D5151-06 (freedom from holes), ASTM D412-06 (tensile strength), ISO 10993-10 (biocompatibility). Dimensions: Length >240mm, thickness >0.05mm. No energy source or software.

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

• ETS Blue Powderfree Nitrile patient exam glove (K121947)

Submission Summary (Full Text)

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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 [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 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 [phone] 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 | [phone] | | | |
| | 1.5 | Email | [e-mail] | | | |
| | 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 | [phone] | | | |
| | 2.5 | Email | [e-mail] | | | |
| | 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 exam<br>glove |
|-----|------------------------|-----------------------------------------------------------------------------------|
| 5.2 | 510(k) Number | K121947 |
| 5.3 | Company | Northstar Healthcare Holdings, 70 Sir John<br>Rogerson'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 Nitrile<br>patient examination<br>gloves, Powderfree, Blue<br>color |
|------------------------------|-------------------------------------------|------------------------------------------------------------------------------------|
| Freedom from Holes | ASTM 06319-10 / ASTM<br>05151-06 | Meets |
| Dimensions | ASTM D6319-10 | Meets |
| Physical Properties | ASTM D6319-10 / ASTM<br>0412-06 | Meets |
| Powder-free residue | ASTM 06319-10 | Meets |
| Bio-compatibility | Primary skin irritation<br>ISO 10993-10 | Non-irritant |
| | Skin/Dermal Sensitization<br>ISO 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 Mpa<br>Ultimate Elongation : > 500% | PASS |

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| | | | | strength :<br>> 14 Mpa | |
|------------------------|-------------------------------|------------------------------------------|------------------------------------------------------------------------|-------------------------------------|------|
| | After<br>Accelerated<br>aging | ASTM<br>06319-10<br>and ASTM<br>0412-06 | ISO 2859-1 /<br>S2/AQL 4.0 | Ultimate<br>Elongation :<br>> 400 % | PASS |
| Powder-free<br>residue | Powder-free<br>residue | ASTM<br>D6319-10<br>and ASTM<br>06124-06 | N=5 | Less than 2<br>mg per glove | PASS |
| Biocompatibility | Primary skin<br>irritation | ISO<br>10993-10 | Under the conditions of the<br>study the device is not an<br>irritant | | PASS |
| | Skin/Dermal<br>Sensitization | ISO<br>10993-10 | Under the conditions of the<br>study the device is not a<br>sensitizer | | PASS |

#### 9.0 Summary of the technological characteristics of device compared to the legally marketed predicate device

| Characteristics | PREDICATE-<br>510(K) :<br>K121947 | SUBJECT DEVICE :<br>K143477 | Acceptance<br>criteria/Standard |
|-----------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|---------------------------------|
| Manufacturer | Northstar<br>Healthcare<br>Holdings, 70 Sir<br>John<br>Rogerson's<br>Quay, Dublin 2,<br>Ireland. | PRIMUS GLOVES<br>PRIVATE LIMITED, Plot<br>No: 14-A, CSEZ,<br>Kakkanad, Cochin,<br>Kerala, India -682037 | |
| Product Name | ETS Blue<br>Powder Free | Nitrile Patient<br>Examination Gloves, | Patient<br>examination |

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| | Nitrile Patient<br>Exam Gloves | Powderfree Blue color<br>gloves | gloves |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for<br>medical purpose<br>that is worn on<br>the Examiners<br>hand to prevent<br>contamination<br>between patient<br>and examiner | Intended for medical<br>purpose that is worn on<br>the Examiners hand to<br>prevent contamination<br>between patient and<br>examiner | Medical Glove<br>Guidance Manual |
| Indication for use | The examination<br>gloves is a<br>disposable<br>device intended<br>for medical<br>purposes that is<br>worn on the<br>examiners hand<br>or finger to<br>prevent<br>contamination<br>between patient<br>and examiner | The examination gloves<br>is a disposable device<br>intended for medical<br>purposes that is worn on<br>the examiners hand or<br>finger to prevent<br>contamination between<br>patient and examiner | Medical Glove<br>Guidance Manual |
| Description | Non sterile<br>powderfree ,<br>examination<br>gloves made of<br>nitrile and<br>colored blue The<br>textured gloves | Non sterile powderfree ,<br>examination gloves<br>made of nitrile and<br>colored blue The<br>textured gloves are<br>provided in sizes Extra<br>Small, Small, Medium, | Medical Glove<br>Guidance Manual |
| | are provided in<br>sizes Extra<br>Small, Small,<br>Medium, Extra<br>Large. The<br>smooth gloves<br>are provided in<br>Sizes Small,<br>Medium, Large<br>and Extra Large | Extra Large. The<br>smooth gloves are<br>provided in Sizes Small,<br>Medium, Large and<br>Extra Large | |
| Presentation | Non sterile<br>gloves are<br>provided in<br>dispenser boxes | Non sterile gloves are<br>provided in dispenser<br>boxes | Medical Glove<br>Guidance Manual |
| Material | Nitrile synthetic<br>latex | Nitrile synthetic latex | ASTM 06319-10<br>LZA product code |
| Non-sterile or<br>sterile | Non Sterile | Non Sterile | Sterility |
| Single Use | Yes | Yes | Disposable/Single<br>use |
| Ambidextrous | Yes | Yes | ASTM D 6319-0 |
| Dimensions | Meets ASTM D<br>6319-10 | Overall length min 240<br>mm ,width varies from<br>70 mm for XS size to<br>120 mm for XL size,<br>thickness in finger and<br>palm has a minimum<br>0.05 mm | Meets ASTM D<br>6319-10<br>-Overall length<br>min 240 mm,<br>width varies from<br>70 mm for XS<br>size to 120 mm<br>for 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±2<br>hrs or 100±2deg<br>C for 22±0.3 hrs |
| Freedom from<br>pinholes | Meets ASTM D<br>5151 -06 and<br>ASTM 06319-10 | Meets ASTM D 5151 -<br>06 (2011) and ASTM<br>06319-10 | ASTM D 5151 -06<br>(2011) and ASTM<br>06319-10 |
| Residual Powder | Meets ASTM D<br>6124-06 | Less than 2 mg per<br>glove | ASTM O 6124-<br>06(2011) : Less<br>than 2 mg per<br>glove |
| Biocompatibility<br>Tests<br><br>ISO 10993-10 | Non-irritant -<br>Primary Skin<br>Irritation In<br>Rabbits<br><br>Non-sensitizer -<br>skin Sensitization<br>in Guinea pigs | Under the conditions of<br>the study the device is<br>not an irritant<br><br>Under the conditions of<br>the study the device is<br>not a sensitizer | Under the<br>conditions of the<br>study the device<br>is not an irritant<br><br>Under the<br>conditions of the<br>study the device<br>is not a sensitizer |
| Labeling | Powderfree,<br>Nitrile patient<br>exam glove<br>Non 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 | *Powderfree,<br>*Nitrile Patient exam<br>glove<br>*Non sterile<br>*Single use only<br>*Blue color<br>*Ambidextrous<br>*Manufactured for<br>*Lot No<br>*Intended use<br>*Quantity<br>*Country of origin | Chapter 4-<br>Labeling-<br>Medical Glove<br>Guidance 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.