Sterile Nitrile Surgical Gloves, Powder-free
Device Facts
| Record ID | K170515 |
|---|---|
| Device Name | Sterile Nitrile Surgical Gloves, Powder-free |
| Applicant | Primus Gloves Pvt Limited |
| Product Code | KGO · General, Plastic Surgery |
| Decision Date | Jun 9, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4460 |
| Device Class | Class 1 |
Intended Use
The powder-free Nitrile Surgical Gloves , is a sterile and single use devise made of synthetic rubber intended to be worn by operation room personnel to protect a surgical wound from contamination. The gloves do not contain lubricating or dusting powder.
Device Story
Sterile, powder-free, anatomic surgical glove made of synthetic nitrile latex compound. Used by operating room personnel to protect surgical wounds from contamination. Device acts as a physical barrier. Performance verified against ASTM D3577-09 standards for dimensions, tensile strength, and elongation. Biocompatibility confirmed via ISO 10993-10 testing (non-irritant, non-sensitizer). Sterility achieved to SAL 10^-6 per ISO 11737-2.
Clinical Evidence
Bench testing only. No clinical data. Performance verified via ASTM D5151-06 (pinholes), ASTM D3577-09 (dimensions, physical properties), ASTM D6124-06 (powder residue), and ISO 10993-10 (biocompatibility). All tests passed.
Technological Characteristics
Material: Synthetic nitrile latex compound. Form factor: Anatomic, textured, sterile, powder-free. Standards: ASTM D3577-09, ASTM D5151-06, ASTM D412-06, ASTM D6124-06, ISO 10993-10, ISO 11737-2. Sterilization: SAL 10^-6.
Indications for Use
Indicated for use by operating room personnel to protect surgical wounds from contamination. Single-use, sterile, powder-free, synthetic rubber gloves.
Regulatory Classification
Identification
A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
Predicate Devices
- POWDER-FREE NITRILE SURGICAL GLOVES, WHITE COLOUR (K140989)
Related Devices
- K171047 — Sterile Polyisoprene Powder Free Surgical Gloves · Better Care Plastic Technology Co., Ltd. · Jun 22, 2017
- K101811 — PROTEGRITY SMT LATEX SURGICALGLOVES · Cardinal Health, Inc. · Oct 15, 2010
- K982586 — POWDER FREE SURGEONS GLOVE · Shiva Medicare , Ltd. · Aug 11, 1998
- K090066 — POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVE · Wear Safe (Malaysia) Sdn. Bhd. · May 15, 2009
- K991317 — POWDER-FREE LATEX SURGEON'S GLOVE SAFESKIN PFS PLUS CONTAINS 50MLGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM · Safeskin Corp. · May 21, 1999
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
June 9, 2017
Primus Gloves Pvt. Limited Jose Paul M Manager Oa & RA Plot No 14a. Cochin Special Economic Zone. Kakkanad Cochin, 682037 IN
Re: K170515
Trade/Device Name: Sterile Nitrile Surgical Gloves, Powder-free Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO Dated: May 4, 2017 Received: May 9, 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 (reporting of medical device
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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.
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,
# Lori A. Wiggins -S6
Lori A. 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) K170515
Device Name
Sterile Nitrile Surgical Gloves Powder-free
Indications for Use (Describe)
The powder-free Nitrile Surgical Gloves , is a sterile and single use devise made of synthetic rubber intended to be worn by operation room personnel to protect a surgical wound from contamination. The gloves do not contain lubricating or dusting powder.
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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K170515
#### 1.0 SUBMITTER
3.0
| 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 | : | +91 484 2413089 |
| 1.5 | Email | : | josepaul@primusgloves.com |
| 1.6 | Contact Person | : | Mr. JOSE PAUL M<br>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.<br>Kakkanad, Cochin, Kerala, India - 682037 |
| 2.3 | Telephone | : | + 91 484 2413063 |
| 2.4 | Fax | : | +91 484 2413089 |
| 2.5 | Email | : | josepaul@primusgloves.com |
| 2.6 | Contact Person | : | Mr. JOSE PAUL M<br>MANAGER – QA & RA |
| Preparation date | | : | June 2, 2017 |
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| 4.0 | Name of the device | | : |
|-----|--------------------|-------------------|----------------------------|
| | 4.1 | Device Name | : STERILE NITRILE SURGICAL |
| | | | GLOVES, POWDER-FREE, |
| | | Trade Name | : PRIMUS NITRILE GLOVES |
| | 4.2 | Common Name | : SURGICAL GLOVES |
| | 4.3 | Classification | : SURGEON"S GLOVES |
| | 4.4 | Class | : CLASS I |
| | 4.5 | Product code | : KGO |
| | 4.6 | Regulation Number | : 21 CFR 878.4460 |
#### 5.0 Identification of the legally marketed predicate device
| 5.1 | Device Name | : | POWDER-FREE NITRILE SURGICAL<br>GLOVES, WHITE COLOUR |
|-----|----------------------|---|--------------------------------------------------------------------------------------------------|
| 5.2 | 510(k) Number | : | k140989 |
| 5.3 | Company | : | Hebei Hongsen Plastics Technology Co Ltd<br>853 Dorchester Ln, Unitb, New Millford,<br>NJ 07646. |
| 5.4 | Device Description | : | Sterile Nitrile Surgical Gloves |
| 5.5 | Classification | : | SURGEON'S GLOVES |
| 5.6 | Class | : | CLASS I |
| 5.7 | Product code | : | KGO |
| 5.8 | Classification Panel | : | General Hospital |
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#### 6.0 Description of the Device
The subject device is a surgical nitrile qlove made of synthetic nitrile latex compound. It is sterile, powder-free. The device is anatomic. The device meets ASTM D 3577-09: Standard specification for Rubber Surgical gloves for Medical Application.
The device is for over-the counter single use.
#### Indications for use 7.0
The powder-free nitrile surgical gloves, is a sterile and single use device made of synthetic rubber intended to be worn by operation room personnel to protect a surgical wound from contamination. The gloves do not contain lubricating or dusting powder.
#### 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. The gloves have the same technological characteristics compared to ASTM or equivalent standards as given below.
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| Characteristics | Test | Test standard | Sampling<br>plan/Inspe<br>ction<br>level/AQL | Sterile Nitrile<br>Surgical<br>gloves powder-<br>free, - PRIMUS | RESULT |
|---------------------------|-----------------------------------|----------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------------|--------|
| Freedom from<br>Pin holes | FDA 1000 ml<br>water leak<br>test | ASTM D5151-06<br>(reap 2011) | ISO 2859-1<br>/ G1/AQL<br>2.5 | PASS | PASS |
| Dimensions | Length | ASTM D 3577-09 | ISO 2859-1<br>/ S2/AQL<br>4.0 | > 265 mm | PASS |
| | Width | ASTM D 3577-09 | ISO 2859-1<br>/ S2/AQL<br>4.0 | 76±6 mm to<br>114±6 mm (<br>sizes 6 to 9) | PASS |
| | Thickness | ASTM D 3577-09 | ISO 2859-1<br>/ S2/AQL<br>4.0 | > 0.10 mm<br>(Cuff, palm &<br>finger) | PASS |
| Physical | Before aging | | ISO 2859-1 | Tensile strength | PASS |
| properties | | ASTM D 3577-09<br>and ASTM D412-06 | / S2/AQL<br>4.0 | > 17 Mpa<br>Ultimate<br>Elongation : ><br>650 %<br>Stress at 500%<br>Elongation | |
| | After<br>Accelerated<br>aging | ASTM D 3577-09<br>and ASTM D412-06 | ISO 2859-1<br>/ S2/AQL<br>4.0 | Tensile strength :<br>> 12 Mpa<br>Ultimate<br>Elongation : ><br>490 % | PASS |
| Powder-free<br>residue | Powder-free<br>residue | ASTM D 3577-09<br>and ASTM<br>D6124-06 | N=5 | Less than 2 mg<br>per glove | PASS |
| Biocompatibility | 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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### 9.0 Summary of the technological characteristics of device compared to the legally marketed predicate device
| Characteristics | PREDICATE – 510(K) :<br>K140989 | SUBJECT DEVICE : | Comparison |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Manufacturer | Hebei Hongsen<br>Plastics Technology Co.<br>Ltd853 Dorchester Ln,<br>Unitb, New Millford,NJ<br>07646. | PRIMUS GLOVES PRIVATE<br>LIMITED, Plot No: 14-A, CSEZ,<br>Kakkanad, Cochin, Kerala,<br>India -682037 | |
| Product Name | POWDER- FREE<br>NITRILE SURGICAL<br>GLOVES, WHITE<br>COLOUR | STERILE NITRILE SURGICAL<br>GLOVES, POWDER-FREE, | Similar |
| Intended Use | The powder-free nitrile<br>surgical glove is a sterile<br>and single use device<br>made of synthetic rubber<br>intended to be worn by<br>operation room personnel<br>to protect a surgical<br>wound from | The powder-free nitrile surgical<br>glove is a sterile and single use<br>device made of synthetic<br>rubber intended to be worn by<br>operation room personnel to<br>protect a surgical wound from<br>contamination. The gloves do<br>not contain lubricating or | Similar |
| | contamination. The<br>gloves do not contain<br>lubricating or dusting<br>powder. | dusting powder. | |
| Indication for use | The powder-free nitrile<br>surgical glove is a sterile<br>and single use device<br>made of synthetic rubber<br>intended to be worn by<br>operation room personnel<br>to protect a surgical<br>wound from<br>contamination. The<br>gloves do not contain<br>lubricating or dusting<br>powder. | The powder-free nitrile surgical<br>glove is a sterile and single use<br>device made of synthetic<br>rubber intended to be worn by<br>operation room personnel to<br>protect a surgical wound from<br>contamination. The gloves do<br>not contain lubricating or<br>dusting powder. | Similar |
| Description | Sterile Nitrile surgical<br>gloves is made of nitrile<br>The textured gloves are<br>provided in sizes<br>6.0,6.5,7.0,7.5,8.0,8.5&9.<br>0. | Sterile Nitrile surgical gloves is<br>made of nitrile The textured<br>gloves are provided in sizes<br>6.0,6.5,7.0,7.5,8.0,8.5&9.0. | Similar |
| Presentation | Sterile gloves are | Sterile gloves are provided in | Similar |
| | provided in pouches | pouches | |
| Material | Nitrile synthetic latex | Nitrile synthetic latex | Similar |
| Single Use | Yes | Yes | Similar |
| Hand Specific | Yes | Yes | Similar |
| Dimensions | Meets ASTM D 3577-09 | Overall length min 265 mm,<br>width varies from 76 mm for<br>6.0 size to 114 mm for 9.0 size,<br>thickness in finger ,Palm & cuff<br>has a minimum 0.10 mm | Similar |
| Tensile Strength | Meets ASTM D 3577-09 | Tensile strength 17 Mpa min for<br>before aging and 12 Mpa min<br>for after aging<br>Aging done at 70 ±2 deg C for<br>166±2 hrs or 100±2deg C for<br>22±0.3 hrs | Similar |
| Ultimate Elongation | Meets ASTM D 3577-09 | Ultimate elongation 650 % min<br>for before aging and 450 % min<br>for after aging. Aging done at<br>70 ±2 deg C for 166±2 hrs or<br>100±2deg C for 22±0.3 hrs | Similar |
| Stress at 500%<br>Elongation | Meets ASTM D 3577-09 | Stress at 500% elongation for<br>before agening is 7.0% min | Similar |
| | Meets ASTM D 5151 -06 | Meets ASTM D 5151 -06 | Similar |
| Freedom from<br>pinholes | and ASTM D 3577-09 | (2011) and ASTM D 3577-09 | |
| Residual Powder | Meets ASTM D 6124-06 | Less than 2 mg per glove | Similar |
| Biocompatibility<br>Tests<br>ISO 10993-10 | Non-irritant -Primary Skin<br>Irritation In Rabbits | Under the conditions of the<br>study the device is not an<br>irritant | Similar |
| | Non-sensitizer - skin<br>Sensitization in Guinea<br>pigs | Under the conditions of the<br>study the device is not a<br>sensitizer | Similar |
| | | | |
| Labeling | Powder-free,<br>Nitrile Surgical glove<br>sterile<br>Single use only<br>Anatomic<br>Manufactured for<br>Lot No<br>Intended use<br>Quantity<br>Country of origin | *Powder-free,<br>* Nitrile Surgical glove<br>glove<br>* sterile<br>*Single use only<br>*Anatomic<br>*Manufactured for<br>*Lot No<br>*Intended use<br>*Quantity<br>*Country of origin | Similar |
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| Sterility | SAL of 10^6 achieved<br>according to ISO 11737-2 | SAL of 10^6 achieved<br>according to ISO 11737-2 | Similar |
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### 10.0 CONCLUSION
The physical performance of the subject device is substantially equivalent to predicate K140989 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, as effective and performs as well as the legally marketed predicate device
