(496 days)
Not Found
No
The device description and intended use clearly define it as a standard examination glove, with no mention of AI or ML capabilities. The performance studies focus on physical properties and biocompatibility, not algorithmic performance.
No
The device is described as a medical glove worn for examination purposes to prevent contamination, not to treat or cure a disease or condition.
No
Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner. It does not perform any diagnostic function.
No
The device is a physical glove made of nitrile latex, not software. The description clearly outlines its material, physical properties, and intended use as a barrier worn on the hand.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- Device Description and Intended Use: The description clearly states the device is a "Nitrile Patient Examination glove" intended to be "worn on the examiners' hand or finger to prevent contamination between patient and examiner." This is a barrier device used during patient examination, not a device used to test samples from the patient.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, reagents, analytical procedures, or any other elements typically associated with IVD devices.
The device described is a Class I medical device (specifically, a patient examination glove) used for barrier protection during medical examinations.
N/A
Intended Use / 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.
Product codes
LZA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner / Medical purposes
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, 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 patient examination gloves, Powderfree, Blue color |
|---|---|---|
| Freedom from Holes | ASTM 06319-10 / ASTM 05151-06 | Meets |
| Dimensions | ASTM D6319-10 | Meets |
| Physical Properties | ASTM D6319-10 / ASTM 0412-06 | Meets |
| Powder-free residue | ASTM 06319-10 | Meets |
| Bio-compatibility | Primary skin irritation ISO 10993-10 | Non-irritant |
| Skin/Dermal Sensitization ISO 10993-10 | Non-sensitizer | |
| Expiration dating/Shelf life | ASTM D7160-05 | Three years |
Performance data of gloves based on ASTM 06319-10 and FDA 1000ml 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 Ultimate Elongation : > 500% | PASS |
| After Accelerated aging | ASTM 06319-10 and ASTM 0412-06 | ISO 2859-1 / S2/AQL 4.0 | Tensile strength : > 14 Mpa Ultimate Elongation : > 400 % | PASS | |
| Powder-free residue | Powder-free residue | ASTM D6319-10 and ASTM 06124-06 | 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 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6250 Non-powdered patient examination glove.
(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
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
1
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 (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 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
2
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.
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."
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 RE
3
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 | +91 484 2413089 | ||||
| 1.5 | josegaul@grimusgloves.com | |||||
| 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 | +91 484 2413089 | ||||
| 2.5 | josegaul@grimusgloves.com | |||||
| 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 |
4
- 4.6 Product code LZA
5.0 ldentification of the leqally marketed predicate device
| 5.1 | Device Name | ETS Blue Powderfree Nitrile patient exam
glove |
|-----|------------------------|-----------------------------------------------------------------------------------|
| 5.2 | 510(k) Number | K121947 |
| 5.3 | Company | Northstar Healthcare Holdings, 70 Sir John
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.
5
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
patient examination
gloves, Powderfree, Blue
color |
|------------------------------|-------------------------------------------|------------------------------------------------------------------------------------|
| Freedom from Holes | ASTM 06319-10 / ASTM
05151-06 | Meets |
| Dimensions | ASTM D6319-10 | Meets |
| Physical Properties | ASTM D6319-10 / ASTM
0412-06 | Meets |
| Powder-free residue | ASTM 06319-10 | Meets |
| Bio-compatibility | Primary skin irritation
ISO 10993-10 | Non-irritant |
| | Skin/Dermal Sensitization
ISO 10993-10 | Non-sensitizer |
| Expiration dating/Shelf life | ASTM D7160-05 | Three years |
6
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 | |
| Ultimate Elongation : > 500% | PASS |
7
| | | | | strength :
14 Mpa | |
|------------------------|-------------------------------|------------------------------------------|------------------------------------------------------------------------|-------------------------------------|------|
| | After
Accelerated
aging | ASTM
06319-10
and ASTM
0412-06 | ISO 2859-1 /
S2/AQL 4.0 | Ultimate
Elongation :
400 % | PASS |
| Powder-free
residue | Powder-free
residue | ASTM
D6319-10
and ASTM
06124-06 | 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 |
9.0 Summary of the technological characteristics of device compared to the legally marketed predicate device
| Characteristics | PREDICATE-
510(K) :
K121947 | SUBJECT DEVICE :
K143477 | Acceptance
criteria/Standard |
|-----------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|---------------------------------|
| Manufacturer | Northstar
Healthcare
Holdings, 70 Sir
John
Rogerson's
Quay, Dublin 2,
Ireland. | PRIMUS GLOVES
PRIVATE LIMITED, Plot
No: 14-A, CSEZ,
Kakkanad, Cochin,
Kerala, India -682037 | |
| Product Name | ETS Blue
Powder Free | Nitrile Patient
Examination Gloves, | Patient
examination |
8
| | Nitrile Patient
Exam Gloves | Powderfree Blue color
gloves | gloves |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for
medical purpose
that is worn on
the Examiners
hand to prevent
contamination
between patient
and examiner | Intended for medical
purpose that is worn on
the Examiners hand to
prevent contamination
between patient and
examiner | Medical Glove
Guidance Manual |
| Indication for use | The 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 | The 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 | Medical Glove
Guidance Manual |
| Description | Non sterile
powderfree ,
examination
gloves made of
nitrile and
colored blue The
textured gloves | Non sterile powderfree ,
examination gloves
made of nitrile and
colored blue The
textured gloves are
provided in sizes Extra
Small, Small, Medium, | Medical Glove
Guidance Manual |
| | are provided in
sizes Extra
Small, Small,
Medium, Extra
Large. The
smooth gloves
are provided in
Sizes Small,
Medium, Large
and Extra Large | Extra Large. The
smooth gloves are
provided in Sizes Small,
Medium, Large and
Extra Large | |
| Presentation | Non sterile
gloves are
provided in
dispenser boxes | Non sterile gloves are
provided in dispenser
boxes | Medical Glove
Guidance Manual |
| Material | Nitrile synthetic
latex | Nitrile synthetic latex | ASTM 06319-10
LZA product code |
| Non-sterile or
sterile | Non Sterile | Non Sterile | Sterility |
| Single Use | Yes | Yes | Disposable/Single
use |
| Ambidextrous | Yes | Yes | ASTM D 6319-0 |
| Dimensions | Meets ASTM D
6319-10 | Overall length min 240
mm ,width varies from
70 mm for XS size to
120 mm for XL size,
thickness in finger and
palm has a minimum
0.05 mm | Meets ASTM D
6319-10
-Overall length
min 240 mm,
width varies from
70 mm for XS
size to 120 mm
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
hrs or 100±2deg
C for 22±0.3 hrs |
| Freedom from
pinholes | Meets ASTM D
5151 -06 and
ASTM 06319-10 | Meets ASTM D 5151 -
06 (2011) and ASTM
06319-10 | ASTM D 5151 -06
(2011) and ASTM
06319-10 |
| Residual Powder | Meets ASTM D
6124-06 | Less than 2 mg per
glove | ASTM O 6124-
06(2011) : Less
than 2 mg per
glove |
| Biocompatibility
Tests
ISO 10993-10 | Non-irritant -
Primary Skin
Irritation In
Rabbits
Non-sensitizer -
skin Sensitization
in Guinea pigs | Under the conditions of
the study the device is
not an irritant
Under the conditions of
the study the device is
not a sensitizer | Under the
conditions of the
study the device
is not an irritant
Under the
conditions of the
study the device
is not a sensitizer |
| Labeling | Powderfree,
Nitrile patient
exam glove
Non sterile
Single use only
Ambidextrous
Blue color
Manufactured for
Lot No
Intended use
Quantity
Country of origin | *Powderfree,
*Nitrile Patient exam
glove
*Non sterile
*Single use only
*Blue color
*Ambidextrous
*Manufactured for
*Lot No
*Intended use
*Quantity
*Country of origin | Chapter 4-
Labeling-
Medical Glove
Guidance Manual |
9
10
11
12
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.