Sterile Nitrile Surgical Gloves, Powder-free

• K Number: K170515
• Device Name: Sterile Nitrile Surgical Gloves, Powder-free
• Manufacturer: Primus Gloves PVT Limited
• Date Cleared: 2017-06-09 ( 108 days)
• Product Code: KGO
• Regulation Number: 878.4460

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 Description

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.

Predicate Devices

KGO, K140989

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard surgical glove and makes no mention of AI or ML technology.

Therapeutic

No
The device is a surgical glove intended for protection, not for treating or rehabilitating a medical condition.

Diagnostic

No
The device is a surgical glove, intended to protect a surgical wound from contamination, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a surgical glove made of synthetic nitrile latex compound, which is a physical hardware product, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to protect a surgical wound from contamination by being worn by operation room personnel. This is a barrier function, not a diagnostic function.
• Device Description: The description focuses on the material (synthetic nitrile rubber), sterility, powder-free nature, and compliance with a standard for surgical gloves. There is no mention of analyzing samples from the human body or providing diagnostic information.
• Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing biological samples (blood, urine, tissue, etc.)
  • Detecting or measuring substances in those samples
  • Providing information for the diagnosis, monitoring, or treatment of a disease or condition

The device is clearly described as a surgical glove, which is a medical device used for protection and barrier purposes in a surgical setting.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

KGO

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

operation room personnel

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Testing was performed for:

• Freedom from Pin holes: FDA 1000 ml water leak test, ASTM D5151-06 (reap 2011), ISO 2859-1 / G1/AQL 2.5, RESULT: PASS
• Dimensions (Length): ASTM D 3577-09, ISO 2859-1 / S2/AQL 4.0, > 265 mm, RESULT: PASS
• Dimensions (Width): ASTM D 3577-09, ISO 2859-1 / S2/AQL 4.0, 76±6 mm to 114±6 mm (sizes 6 to 9), RESULT: PASS
• Dimensions (Thickness): ASTM D 3577-09, ISO 2859-1 / S2/AQL 4.0, > 0.10 mm (Cuff, palm & finger), RESULT: PASS
• 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, RESULT: PASS
• 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 %, RESULT: PASS
• Powder-free residue: ASTM D 3577-09 and ASTM D6124-06, N=5, Less than 2 mg per glove, RESULT: PASS
• Biocompatibility (Primary skin irritation): ISO 10993-10, Under the conditions of the study the device is not an irritant, RESULT: PASS
• Biocompatibility (Skin/Dermal Sensitization): ISO 10993-10, Under the conditions of the study the device is not a sensitizer, RESULT: PASS
• Sterility: ISO 11737-02, Sterile, RESULT: Pass

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K140989

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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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 [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,

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,
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
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
GLOVES, WHITE COLOUR |
|-----|----------------------|---|--------------------------------------------------------------------------------------------------|
| 5.2 | 510(k) Number | : | K140989 |
| 5.3 | Company | : | Hebei Hongsen Plastics Technology Co Ltd
853 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 |

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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
plan/Inspe
ction
level/AQL | Sterile Nitrile
Surgical
gloves powder-
free, - PRIMUS | RESULT |
|---------------------------|-----------------------------------|----------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------------|--------|
| Freedom from
Pin holes | FDA 1000 ml
water leak
test | ASTM D5151-06
(reap 2011) | ISO 2859-1
/ G1/AQL
2.5 | PASS | PASS |
| Dimensions | Length | ASTM D 3577-09 | ISO 2859-1
/ S2/AQL
4.0 | > 265 mm | PASS |
| | Width | ASTM D 3577-09 | ISO 2859-1
/ S2/AQL
4.0 | 76±6 mm to
114±6 mm (
sizes 6 to 9) | PASS |
| | Thickness | ASTM D 3577-09 | ISO 2859-1
/ S2/AQL
4.0 | > 0.10 mm
(Cuff, palm &
finger) | PASS |
| Physical | Before aging | | ISO 2859-1 | Tensile strength | PASS |
| properties | | ASTM D 3577-09
and ASTM D412-06 | / S2/AQL
4.0 | > 17 Mpa
Ultimate
Elongation : >
650 %
Stress at 500%
Elongation | |
| | 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 |
| Powder-free
residue | Powder-free
residue | ASTM D 3577-09
and ASTM
D6124-06 | N=5 | Less than 2 mg
per glove | PASS |
| Biocompatibility | Primary skin
irritation | ISO 10993-10 | Under the conditions of the
study the device is not an
irritant | | PASS |
| | Skin/Dermal
Sensitization | ISO 10993-10 | Under the conditions of the
study the device is not a
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) :
K140989 | SUBJECT DEVICE : | Comparison |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Manufacturer | Hebei Hongsen
Plastics Technology Co.
Ltd853 Dorchester Ln,
Unitb, New Millford,NJ
07646. | PRIMUS GLOVES PRIVATE
LIMITED, Plot No: 14-A, CSEZ,
Kakkanad, Cochin, Kerala,
India -682037 | |
| Product Name | POWDER- FREE
NITRILE SURGICAL
GLOVES, WHITE
COLOUR | STERILE NITRILE SURGICAL
GLOVES, POWDER-FREE, | Similar |
| Intended Use | The powder-free nitrile
surgical glove 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 | The powder-free nitrile surgical
glove 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 | Similar |
| | contamination. The
gloves do not contain
lubricating or dusting
powder. | dusting powder. | |
| Indication for use | The powder-free nitrile
surgical glove 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. | The powder-free nitrile surgical
glove 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. | Similar |
| Description | Sterile Nitrile surgical
gloves is made of nitrile
The textured gloves are
provided in sizes
6.0,6.5,7.0,7.5,8.0,8.5&9.
0. | Sterile Nitrile surgical gloves is
made of nitrile The textured
gloves are provided in sizes
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,
width varies from 76 mm for
6.0 size to 114 mm for 9.0 size,
thickness in finger ,Palm & cuff
has a minimum 0.10 mm | Similar |
| Tensile Strength | Meets ASTM D 3577-09 | Tensile strength 17 Mpa min for
before aging and 12 Mpa min
for after aging
Aging done at 70 ±2 deg C for
166±2 hrs or 100±2deg C for
22±0.3 hrs | Similar |
| Ultimate Elongation | Meets ASTM D 3577-09 | Ultimate elongation 650 % min
for before aging and 450 % min
for after aging. Aging done at
70 ±2 deg C for 166±2 hrs or
100±2deg C for 22±0.3 hrs | Similar |
| Stress at 500%
Elongation | Meets ASTM D 3577-09 | Stress at 500% elongation for
before agening is 7.0% min | Similar |
| | Meets ASTM D 5151 -06 | Meets ASTM D 5151 -06 | Similar |
| Freedom from
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
Tests
ISO 10993-10 | Non-irritant -Primary Skin
Irritation In Rabbits | Under the conditions of the
study the device is not an
irritant | Similar |
| | Non-sensitizer - skin
Sensitization in Guinea
pigs | Under the conditions of the
study the device is not a
sensitizer | Similar |
| | | | |
| Labeling | Powder-free,
Nitrile Surgical glove
sterile
Single use only
Anatomic
Manufactured for
Lot No
Intended use
Quantity
Country of origin | *Powder-free,

• Nitrile Surgical glove
  glove
• sterile
  *Single use only
  *Anatomic
  *Manufactured for
  *Lot No
  *Intended use
  *Quantity
  *Country of origin | Similar |
  | | | | |
  | | | | |
  | | | | |
  | | | | |
  | | | | |
  | | | | |
  | | | | |
  | | | | |
  | | | | |
  | | | | |
  | Sterility | SAL of 10^6 achieved
  according to ISO 11737-2 | SAL of 10^6 achieved
  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