STERILE VINYL EXAMINATION GLOVES, Powder Free

K170612 · Primus Gloves Pvt Limited · LYZ · Oct 23, 2017 · General Hospital

Device Facts

• Record ID: K170612
• Device Name: STERILE VINYL EXAMINATION GLOVES, Powder Free
• Applicant: Primus Gloves Pvt Limited
• Product Code: LYZ · General Hospital
• Decision Date: Oct 23, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

The POWDER FREE patient examination gloves 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

Sterile, powder-free, ambidextrous vinyl examination glove; manufactured from synthetic polyvinyl chloride compound. Device functions as a physical barrier to prevent contamination between patient and examiner. Used in clinical settings; worn by healthcare professionals. Provides protection via material integrity; tested for pinholes, tensile strength, and elongation. Benefits patient and examiner by reducing risk of cross-contamination during medical examinations.

Clinical Evidence

Bench testing only. Performance data includes: freedom from holes (ASTM D5151-06), dimensions (ASTM D5250-06), physical properties (tensile strength >11 MPa, ultimate elongation >300% per ASTM D412-06), powder residue (<2 mg/glove per ASTM D6124-06), and biocompatibility (non-irritant, non-sensitizer per ISO 10993-10). Sterility validated per ISO 11737-02. Shelf life established at three years per ASTM D7160-05.

Technological Characteristics

Material: Polyvinyl chloride (PVC). Form factor: Ambidextrous, sterile, powder-free glove. Dimensions: Length >230 mm, width 85-115 mm, thickness >0.05 mm (finger) and >0.08 mm (palm). Standards: ASTM D5250-06, ASTM D5151-06, ASTM D412-06, ASTM D6124-06, ASTM D7160-05. Biocompatibility: ISO 10993-10. Sterilization: ISO 11737-02.

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

• POWDER FREE STERILE VINYL EXAMINATION GLOVE (Clear and Yellow) (K053523)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo.

October 23, 2017

Primus Gloves, Pvt. Limited Jose Paul M Manager QA & RA Plot No 14-A, Cochin Special Economic Zone, Kakkanad Cochin, 682037 INDIA

Re: K170612

Trade/Device Name: Sterile Vinyl Examination Gloves, Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: September 25, 2017 Received: September 28, 2017

Dear 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 of medical device-related 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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

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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 (DICE) 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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael J. Ryan -S

for Tina Kiang, Ph.D. 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) K170612

Device Name STERILE VINYL EXAMINATION GLOVES, POWDER FREE

Indications for Use (Describe)

The POWDER FREE patient examination gloves 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)

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#### SUBMITTER 1.0

| 1.1 | Company Name | : | PRIMUS GLOVES PRIVATE LIMITED |
|-----|----------------|---|-----------------------------------------------------------------------------------------|
| 1.2 | Address | : | Plot No: 14-A, Cochin Special Economic Zone<br>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<br>MANAGER – QA & RA |

#### OFFICIAL CORRESPONDENT 2.0

| 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 | <a href="mailto:[e-mail]">[e-mail]</a> |
| 2.6 Contact Person | Mr. JOSE PAUL M |
| | MANAGER — QA & RA |
| 3.0 Preparation date | 13th OCTOBER, 2017 |
| 4.0 Name of the device | |
| 4.1 Device Name | STERILE VINYL EXAMINATION GLOVES, POWDER FREE, |
| 4.2 Trade Name | PRIMUS VINYL EXAMINATION GLOVES PF |
| 4.3 Common Name | PATIENT EXAMINATION GLOVES |
| 4.4 Classification | PATIENT EXAMINATION GLOVES |
| 4.5 Class | CLASS I |
| 4.6 Product code | LYZ |
| 4.7 510(K)Number | K 170612 |

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## K170612

#### 5.0 Identification of the legally marketed predicate device

| 5.1 | Device Name | POWDER FREE STERILE VINYL EXAMINATION<br>GLOVE (Clear and Yellow) |
|-----|----------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| 5.2 | 510(k) Number | K 053523 |
| 5.3 | Company | Shijiazhuang Hongxiang Plastics Products Co Ltd<br>C/O Ms. Micky Lin, Gloveco, Inc. 3973 Schaefer Ave.<br>Chino, California 97710 |
| 5.4 | Device Description | POWDER FREE STERILE VINYL EXAMINATION<br>GLOVES(Clear and Yellow) |
| 5.5 | Classification | PATIENT EXAMINATION GLOVES |
| 5.6 | Class | CLASS I |
| 5.7 | Product code | LYZ |
| 5.8 | Classification Panel | General Hospital |

#### 6.0 Description of the Device

The subject device is a vinyl examination glove made of synthetic poly vinyl chloride compound. It is sterile, POWDER FREE. The device is ambidextrous. The device meets ASTM D 5250-06: Standard specification for poly vinyl chloride gloves for medical application.

The device is for over-the counter single use.

#### 7.0 Indications for use

The POWDER FREE patient examination gloves 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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#### Summary of performance data 8.0

There is no difference in technological characteristics compared to the predicate device. Gloves are made from Poly vinyl chloride compound, sterile, POWDER FREE. The gloves have the same technological characteristics compared to ASTM or equivalent standards as given below,

| Characteristics | Standards | Performance of Sterile<br>Vinyl examination gloves,<br>POWDER FREE |
|---------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Freedom from Holes | ASTM D 5250-06/ ASTM<br>D5151-06 | Meets |
| Dimensions | ASTM D 5250-06 | Meets |
| Physical Properties | ASTM D 5250-06 / ASTM<br>D412-06 | Meets |
| POWDER FREE<br>residue | ASTM D 5250-06 | Meets |
| Bio-compatibility | Primary skin irritation<br>ISO 10993-10<br>Skin/Dermal Sensitization<br>ISO 10993-10 | Non-irritant<br>Non-sensitizer |
| Expiration<br>dating/Shelf life | ASTM D7160-05 | Three years |
| Sterility | ISO 11737-02 | Meets |

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Performance data of gloves based on ASTM D 5250-06and FDA 1000ml water leak test

| ASTM D 5250-06and FDA 1000 ml water leak test | | | | | |
|-----------------------------------------------|-----------------------------------|-------------------------------------------|------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Characteristics | Test | Test<br>standard | Sampling<br>plan/Inspect<br>ion<br>level/AQL | sterile, vinyl<br>examination<br>gloves -<br>PRIMUS | RESULT |
| Freedom from<br>Pin holes | FDA 1000 ml<br>water leak<br>test | ASTM D5151-<br>06 (reap<br>2011) | ISO 2859-1 /<br>G1/AQL 2.5 | PASS | PASS |
| Dimensions | Length | ASTM D<br>5250-06 | ISO 2859-1 /<br>S2/AQL 4.0 | > 230 mm | PASS |
| | Width | ASTM D<br>5250-06 | ISO 2859-1 /<br>S2/AQL 4.0 | 85±5 mm to<br>115±5 mm (<br>sizes S to XL) | PASS |
| | Thickness | ASTM D<br>5250-06 | ISO 2859-1 /<br>S2/AQL 4.0 | > 0.05 in finger<br>& 0.08 in palm | PASS |
| | Physical<br>properties | Before aging | ASTM D<br>5250-06and<br>ASTM D412-<br>06 | ISO 2859-1 /<br>S2/AQL 4.0 | Tensile<br>strength :<br>> 11 Mpa<br>Ultimate<br>Elongation : ><br>300 % |
| After<br>Accelerated<br>aging | | ASTM D<br>5250-06and<br>ASTM D412-<br>06 | ISO 2859-1 /<br>S2/AQL 4.0 | Tensile<br>strength :<br>> 11 Mpa<br>Ultimate<br>Elongation : ><br>300 % | PASS |
| POWDER FREE<br>residue | POWDER<br>FREE<br>residue | ASTM D<br>5250-06and<br>ASTM D6124-<br>06 | N=5 | Less than 2 mg<br>per glove | PASS |
| Bio compatibility | Primary skin<br>irritation | ISO 10993-10 | Under the conditions of the<br>study the device is not an<br>irritant | | PASS |
| | Skin/Dermal<br>Sensitization | ISO 10993-10 | Under the conditions of the<br>study the device is not a<br>sensitizer | | PASS |
| Sterility | | ISO 11737-02 | Sterile | | Pass |

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#### Predicate comparison chart 9.0

| Characteristics | PREDICATE – 510(K) :<br>K053523 | SUBJECT DEVICE | Acceptance<br>criteria/Standard |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Manufacturer | Shijiazhuang Hongxiang<br>Plastics Products Co Ltd<br>C/O Ms. Micky Lin, Gloveco,<br>Inc. 3973 Schaefer Ave.<br>Chino, California 97710 | PRIMUS GLOVES PRIVATE<br>LIMITED, Plot No: 14-A,<br>CSEZ, Kakkanad, Cochin,<br>Kerala, India -682037 | |
| Product Name | POWDER FREE STERILE<br>VINYL EXAMINATION<br>GLOVES(Clear and Yellow) | STERILE VINYL<br>EXAMINTION<br>GLOVES, POWDER FREE | Similar |
| Intended Use | The patient examination<br>gloves is a disposable device<br>intended for medical<br>purposes that is worn on the<br>examiners hand or finger to<br>prevent contamination<br>between patient and<br>examiner | The patient examination<br>gloves is a disposable device<br>intended for medical<br>purposes that is worn on the<br>examiners hand or finger to<br>prevent contamination<br>between patient and<br>examiner | Similar |
| Indication for<br>use | The patient examination<br>gloves is a disposable device<br>intended for medical<br>purposes that is worn on the<br>examiners hand or finger to<br>prevent contamination<br>between patient and<br>examiner | The patient examination<br>gloves is a disposable device<br>intended for medical<br>purposes that is worn on the<br>examiners hand or finger to<br>prevent contamination<br>between patient and<br>examiner | Similar |
| Description | POWDER FREE sterile Vinyl<br>Examination glove(clear and<br>yellow) is made of poly vinyl<br>chloride The gloves are<br>provided in Sizes Small,<br>Medium, Large and Extra<br>Large | sterile Vinyl Examination<br>gloves POWDER FREE is<br>made of poly vinyl chloride<br>The gloves are provided in<br>Sizes Small, Medium, Large<br>and Extra Large | Similar |
| Presentation | Sterile gloves are<br>provided in pouches | Sterile gloves are<br>provided in pouches | Similar |
| Material | Poly Vinyl Chlorid | Poly Vinyl Chlorid | Similar |
| Non-sterile or sterile | Sterile | Sterile | Similar |
| Single Use | Yes | Yes | Similar |
| Ambidextrous | Yes | Yes | Similar |
| Dimensions | Meets ASTM D 5250-<br>06 | Overall length min 230<br>mm ,width varies from<br>80 mm for small size<br>to 115 mm for Large<br>size, thickness in<br>finger 0.05 mm min<br>&,Palm 0.08 mm min | Similar |
| | | Tensile strength 11<br>Mpa min for before &<br>after aging<br>Aging done at 70 ±2<br>deg C for 72±2 hrs | Similar |
| Tensile Strength | Meets ASTM D 5250-<br>06 | | |
| Ultimate Elongation | Meets ASTM D 5250-<br>06 | Ultimate elongation<br>300 % min for before<br>& after aging. Aging<br>done at 70 ±2 deg C<br>for 72±2 hrs | Similar |
| Freedom from<br>pinholes | Meets ASTM D 5151 -<br>06 and ASTM D<br>5250-06 | Meets ASTM D 5151 -<br>06 (2011) and ASTM<br>D 5250-06 | Similar |
| Residual Powder | Meets ASTM D 6124-<br>06 | Less than 2 mg per<br>glove | Similar |
| Biocompatibility Tests | Non-irritant -Primary<br>Skin Irritation In<br>Rabbits | Under the conditions<br>of the study the device<br>is not an irritant | Similar |
| | ISO 10993-10 | Non-sensitizer - skin<br>Sensitization in<br>Guinea pigs | Under the conditions<br>of the study the device<br>is not a sensitizer |
| Labeling | POWDER FREE,<br>Vinyl Examination<br>glove<br>sterile<br>Single use only<br>Ambidextrous<br>Manufactured for<br>Lot No<br>Intended use<br>Quantity<br>Country of origin | *POWDER FREE,<br>* Vinyl Examination<br>glove<br>* sterile<br>*Single use only<br>* Ambidextrous<br>*Manufactured for<br>*Lot No<br>*Intended use<br>*Quantity<br>*Country of origin | Similar |
| Sterility | Sterile | Sterile | Similar |

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# K170612

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#### CONCLUSION 10.0

Based on the intended use, physical properties and technological characteristics, the subject device is as safe, as effective and performs as well as the legally marketed predicate device.