(108 days)
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.
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.
This document describes the performance data and acceptance criteria for the "Sterile Nitrile Surgical Gloves, Powder-free" manufactured by Primus Gloves Pvt. Limited (K170515).
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Test Standard / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Freedom from Pinholes | FDA 1000 ml water leak test, ASTM D5151-06 (reap 2011), ISO 2859-1 / G1/AQL 2.5 | PASS |
| Dimensions - Length | ASTM D 3577-09, ISO 2859-1 / S2/AQL 4.0, > 265 mm | PASS (> 265 mm) |
| Dimensions - Width | ASTM D 3577-09, ISO 2859-1 / S2/AQL 4.0, 76±6 mm to 114±6 mm (sizes 6 to 9) | PASS (76±6 mm to 114±6 mm) |
| Dimensions - Thickness | ASTM D 3577-09, ISO 2859-1 / S2/AQL 4.0, > 0.10 mm (Cuff, palm & finger) | PASS (> 0.10 mm) |
| Physical properties - Before aging | ASTM D 3577-09 and ASTM D412-06, ISO 2859-1 / S2/AQL 4.0, Tensile strength: > 17 Mpa, Ultimate Elongation: > 650 %, Stress at 500% Elongation | PASS (> 17 Mpa, > 650 %) |
| Physical properties - After Accelerated aging | ASTM D 3577-09 and ASTM D412-06, ISO 2859-1 / S2/AQL 4.0, Tensile strength: > 12 Mpa, Ultimate Elongation: > 490 % | PASS (> 12 Mpa, > 490 %) |
| Powder-free residue | ASTM D 3577-09 and ASTM D6124-06, N=5, Less than 2 mg per glove | PASS (Less than 2 mg per glove) |
| Biocompatibility - Primary skin irritation | ISO 10993-10, Not an irritant | PASS (Not an irritant) |
| Biocompatibility - Skin/Dermal Sensitization | ISO 10993-10, Not a sensitizer | PASS (Not a sensitizer) |
| Sterility | ISO 11737-02, Sterile (SAL of 10^-6 achieved) | Pass (SAL of 10^-6 achieved) |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Sampling plan/Inspection level/AQL" for some tests:
- Freedom from Pinholes: G1/AQL 2.5 (per ISO 2859-1)
- Dimensions: S2/AQL 4.0 (per ISO 2859-1)
- Physical properties (Before and After aging): S2/AQL 4.0 (per ISO 2859-1)
- Powder-free residue: N=5
The specific total sample sizes (number of gloves tested) for each characteristic are not explicitly stated as a single number but are derived from the specified AQL (Acceptance Quality Limit) and inspection levels per ISO 2859-1.
Data Provenance: The document does not explicitly state the country of origin of the test data (e.g., where the testing labs are located) or whether the data is retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This document describes the testing of a medical device (surgical gloves) against recognized consensus standards (ASTM, ISO, FDA). The "ground truth" for these tests are the objective measurements and pass/fail criteria defined by these standards, not expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set:
Not applicable. The tests performed are objective measurements (e.g., dimensions, tensile strength, leak test) against defined numerical or qualitative standards. There is no mention of, nor a need for, human adjudication for these types of tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices to assess the impact on human reader performance. The device here is a physical product (surgical gloves).
6. If a Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, the studies conducted are standalone performance studies of the device itself, without human-in-the-loop performance. The various physical, chemical, and biological tests assess the inherent properties and performance of the glove.
7. The Type of Ground Truth Used:
The "ground truth" used for these studies is based on:
- Consensus Standards: Specifically ASTM D 3577-09, ASTM D412-06, ASTM D5151-06 (reap 2011), ASTM D6124-06, ISO 2859-1, ISO 10993-10, and ISO 11737-02.
- Defined Pass/Fail Criteria: Each test has numerical or qualitative criteria for what constitutes a "PASS" (e.g., tensile strength > 17 Mpa, less than 2 mg powder per glove, not an irritant).
8. The Sample Size for the Training Set:
Not applicable. This device is a physical product (surgical gloves) and does not involve AI/machine learning algorithms that require a "training set" in the context of image analysis or diagnostic models. The manufacturing process itself (which is optimized over time) could be considered a form of "training," but not in the data science sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" in the context of AI/ML for this device. The quality control and manufacturing processes ensure the product consistently meets the established standards.
{0}------------------------------------------------
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a triple helix-like structure extending from the heads.
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
{1}------------------------------------------------
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
{2}------------------------------------------------
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
1.0 SUBMITTER
3.0
| 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 | : | +91 484 2413089 |
| 1.5 | : | josepaul@primusgloves.com | |
| 1.6 | Contact Person | : | Mr. JOSE PAUL MMANAGER – 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 | : | +91 484 2413089 |
| 2.5 | : | josepaul@primusgloves.com | |
| 2.6 | Contact Person | : | Mr. JOSE PAUL MMANAGER – QA & RA |
| Preparation date | : | June 2, 2017 |
{4}------------------------------------------------
| 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 SURGICALGLOVES, WHITE COLOUR |
|---|---|---|---|
| 5.2 | 510(k) Number | : | K140989 |
| 5.3 | Company | : | Hebei Hongsen Plastics Technology Co Ltd853 Dorchester Ln, Unitb, New Millford,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 |
{5}------------------------------------------------
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.
{6}------------------------------------------------
| Characteristics | Test | Test standard | Samplingplan/Inspectionlevel/AQL | Sterile NitrileSurgicalgloves powder-free, - PRIMUS | RESULT |
|---|---|---|---|---|---|
| Freedom fromPin holes | FDA 1000 mlwater leaktest | ASTM D5151-06(reap 2011) | ISO 2859-1/ G1/AQL2.5 | PASS | PASS |
| Dimensions | Length | ASTM D 3577-09 | ISO 2859-1/ S2/AQL4.0 | > 265 mm | PASS |
| Width | ASTM D 3577-09 | ISO 2859-1/ S2/AQL4.0 | 76±6 mm to114±6 mm (sizes 6 to 9) | PASS | |
| Thickness | ASTM D 3577-09 | ISO 2859-1/ S2/AQL4.0 | > 0.10 mm(Cuff, palm &finger) | PASS | |
| Physical | Before aging | ISO 2859-1 | Tensile strength | PASS | |
| properties | ASTM D 3577-09and ASTM D412-06 | / S2/AQL4.0 | > 17 MpaUltimateElongation : >650 %Stress at 500%Elongation | ||
| AfterAcceleratedaging | ASTM D 3577-09and ASTM D412-06 | ISO 2859-1/ S2/AQL4.0 | Tensile strength :> 12 MpaUltimateElongation : >490 % | PASS | |
| Powder-freeresidue | Powder-freeresidue | ASTM D 3577-09and ASTMD6124-06 | N=5 | Less than 2 mgper glove | PASS |
| Biocompatibility | Primary skinirritation | ISO 10993-10 | Under the conditions of thestudy the device is not anirritant | PASS | |
| Skin/DermalSensitization | ISO 10993-10 | Under the conditions of thestudy the device is not asensitizer | PASS | ||
| Sterility | ISO 11737-02 | Sterile | Pass |
{7}------------------------------------------------
{8}------------------------------------------------
9.0 Summary of the technological characteristics of device compared to the legally marketed predicate device
| Characteristics | PREDICATE – 510(K) :K140989 | SUBJECT DEVICE : | Comparison |
|---|---|---|---|
| Manufacturer | Hebei HongsenPlastics Technology Co.Ltd853 Dorchester Ln,Unitb, New Millford,NJ07646. | PRIMUS GLOVES PRIVATELIMITED, Plot No: 14-A, CSEZ,Kakkanad, Cochin, Kerala,India -682037 | |
| Product Name | POWDER- FREENITRILE SURGICALGLOVES, WHITECOLOUR | STERILE NITRILE SURGICALGLOVES, POWDER-FREE, | Similar |
| Intended Use | The powder-free nitrilesurgical glove is a sterileand single use devicemade of synthetic rubberintended to be worn byoperation room personnelto protect a surgicalwound from | The powder-free nitrile surgicalglove is a sterile and single usedevice made of syntheticrubber intended to be worn byoperation room personnel toprotect a surgical wound fromcontamination. The gloves donot contain lubricating or | Similar |
| contamination. Thegloves do not containlubricating or dustingpowder. | dusting powder. | ||
| Indication for use | The powder-free nitrilesurgical glove is a sterileand single use devicemade of synthetic rubberintended to be worn byoperation room personnelto protect a surgicalwound fromcontamination. Thegloves do not containlubricating or dustingpowder. | The powder-free nitrile surgicalglove is a sterile and single usedevice made of syntheticrubber intended to be worn byoperation room personnel toprotect a surgical wound fromcontamination. The gloves donot contain lubricating ordusting powder. | Similar |
| Description | Sterile Nitrile surgicalgloves is made of nitrileThe textured gloves areprovided in sizes6.0,6.5,7.0,7.5,8.0,8.5&9.0. | Sterile Nitrile surgical gloves ismade of nitrile The texturedgloves are provided in sizes6.0,6.5,7.0,7.5,8.0,8.5&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,width varies from 76 mm for6.0 size to 114 mm for 9.0 size,thickness in finger ,Palm & cuffhas a minimum 0.10 mm | Similar |
| Tensile Strength | Meets ASTM D 3577-09 | Tensile strength 17 Mpa min forbefore aging and 12 Mpa minfor after agingAging done at 70 ±2 deg C for166±2 hrs or 100±2deg C for22±0.3 hrs | Similar |
| Ultimate Elongation | Meets ASTM D 3577-09 | Ultimate elongation 650 % minfor before aging and 450 % minfor after aging. Aging done at70 ±2 deg C for 166±2 hrs or100±2deg C for 22±0.3 hrs | Similar |
| Stress at 500%Elongation | Meets ASTM D 3577-09 | Stress at 500% elongation forbefore agening is 7.0% min | Similar |
| Meets ASTM D 5151 -06 | Meets ASTM D 5151 -06 | Similar | |
| Freedom frompinholes | 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 |
| BiocompatibilityTestsISO 10993-10 | Non-irritant -Primary SkinIrritation In Rabbits | Under the conditions of thestudy the device is not anirritant | Similar |
| Non-sensitizer - skinSensitization in Guineapigs | Under the conditions of thestudy the device is not asensitizer | Similar | |
| Labeling | Powder-free,Nitrile Surgical glovesterileSingle use onlyAnatomicManufactured forLot NoIntended useQuantityCountry of origin | Powder-free, Nitrile Surgical gloveglove* sterile*Single use only*Anatomic*Manufactured for*Lot No*Intended use*Quantity*Country of origin | Similar |
| Sterility | SAL of 10^6 achievedaccording to ISO 11737-2 | SAL of 10^6 achievedaccording to ISO 11737-2 | Similar |
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
{12}------------------------------------------------
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
§ 878.4460 Non-powdered surgeon's glove.
(a)
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.(b)
Classification. Class I (general controls).