(336 days)
Not Found
No
The device description and intended use clearly define a standard examination glove, with no mention of AI/ML or related technologies.
No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, which is a protective function, not a therapeutic one. It does not treat, cure, or prevent a disease or condition in a patient.
No
Explanation: The device is described as a "patient examination glove" intended to prevent contamination between a patient and an examiner. Its function is protective, not diagnostic. There is no mention of it being used to detect, diagnose, or monitor any disease, condition, or other health parameters.
No
The device is a physical examination glove, which is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "patient examination glove...worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a physical barrier device used for protection, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the material (synthetic rubber latex, nitrile), manufacturing process (powder-free, surface treatment), and physical characteristics (ambidextrous). There is no mention of reagents, calibrators, controls, or any components typically associated with in vitro diagnostic tests.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes or markers
- Providing diagnostic information
- Using reagents or test kits
Therefore, this device falls under the category of a medical device used for barrier protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A 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.
Product codes
LZA
Device Description
The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergo surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous; i.e. can be worn on right hand or left hand.
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
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
The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above (ASTM Requirements).
Key Metrics
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
510(K) summary Page 1 of 5
510(k) SUMMARY
JUN 3 0 2014
1.0 Submitter:
| Name: | Mr. Francis V |
|---|---|
| Address: | Advanced Healthcare Products Sdn Bhd |
| Lot 60 & 61, Lorong Senawang 3/2, | |
| Senawang Industrial Estate, | |
| 70450 Seremban, Negeri Sembilan Darul Khusus, | |
| Malaysia. | |
| Phone No.: | +60 6 678 4188 |
| Fax No.: | +60 6 678 4727 |
Date of Summary Prepared: June 27, 2014
LZA)
2.0 Name of the device:
Powder Free Blue Nitrile Patient Examination Glove, Non-Sterile
Common Name: Patient Examination Glove Classification Name: Patient Examination Gloves (21 CFR 880.6250 product code
Regulatory Class I
3.0 Identification of The Legally Marketed Devices that equivalency is claimed:
Dermagrip Ultra Powder Free Blue Nitrile Patient Examination Gloves Non-Sterile (and various brandnames) 510(k) : K110979 MDL : D133849 Regulatory Class I Product Code : LZA
4.0 Description of The Device:
| Predicate
K110979 | Current
K132354 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dermagrip Ultra Powder Free Blue
Nitrile Patient Examination Gloves
Non-Sterile (and various brandnames)
meets all the requirements of ASTM
standard D6319-10 and FDA 21 CFR
880.6250. | Powder Free Blue Nitrile Patient
Examination Glove, Non-Sterile meets
all the requirements of ASTM standard
D6319-10 and FDA 21 CFR 880.6250. |
| | The powder free nitrile examination
glove is manufactured from synthetic
rubber latex. Inner surface of gloves
undergo surface treatment process to
produce a smooth surface that assists
the user in donning the gloves with ease
without using any lubricant such as
powder on the glove surface. The glove
is ambidextrous; i.e. can be worn on
right hand or left hand. |
1
5.0 Intended Use of the Device:
A 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.
6.0 Summary of the Technological Characteristics of the Device:
The Powder Free Blue Nitrile Patient Examination Glove, Non-Sterile are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | |
|---|---|---|---|
| Predicate | |||
| K110979 | Current | ||
| K132354 | |||
| Dimensions | ASTM D6319-10 | Meets | Meets |
| Length min 230mm | |||
| Width min 95±10 | |||
| Physical Properties | ASTM D6319-10 | Meets | Meets |
Before Aging
Tensile Strength
min 14 MPa
Ultimate Elongation
Min 500%
After Aging
Tensile Strength min 14
MPa
Ultimate Elongation
Min 400% |
| Thickness | ASTM D6319-10 | Meets | Meets
Finger min 0.05mm
Palm min 0.05mm |
| Powder Free | ASTM D6124-06
(Reapproved 2011) | Meets
≤ 2 mg/glove | Meets
≤ 2 mg/glove |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | |
| | | Predicate
K110979 | Current
K132354 |
| Biocompatibility | Primary Skin
Irritation -
ISO 10993-
10:2010(E) &
Consumer Product
Safety Commission,
Tittle 16, Chapter
II, Part 1500 | Passes
(Not a primary
skin irritant)
There was no
erythema or
oedema noted on
abraded or non-
abraded sites at
$24\pm1$ hours and
$72\pm1$ hours. The
Primary Irritation
Index (PII) of test
material was "0". | Passes
(Not a primary skin
irritant)
There was no
erythema or oedema
noted on abraded or
non-abraded sites at
$24\pm1$ hours and $72\pm1$
hours. The Primary
Irritation Index (PII)
of test material was
"0". |
| | Dermal
Sensitization -
ISO 10993-
10:2010(E) &
Consumer Product
Safety Commission,
Tittle 16, Chapter
II, Part
1500.3(c)(4) | Passes
(Not a contact
sensitizer)
There was no
positive allergic
reaction observed
during the
challenge phase
(at $0\pm2$ , $24\pm2$
hours and $48\pm2$
hours) in animals
treated with the
test material and
negative control. | Passes
(Not a contact
sensitizer)
There was no positive
allergic reaction
observed during the
challenge phase (at
$0\pm2$ , $24\pm2$ hours and
$48\pm2$ hours) in
animals treated with
the test material and
negative control. |
| Watertight (1000ml) | ASTM D5151-06
(Reapproved 2011) | Passes | Passes
AQL 2.5 |
| Intended Use | | The powder free
examination glove
is a specialty
medical glove
which is a
disposable device
intended for
medical purposes
that is worn on
the examiner's
hand or forefinger
to prevent
contamination
between examiner
and patient bodily
fluids, waste or
environment. | A 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. |
| CHARACTERISTICS STANDARDS | | DEVICE PERFORMANCE | |
| | | Predicate
K110979 | Current
K132354 |
| Material | ASTM D6319-10 | Nitrile | Nitrile
Sulphur
Zinc Oxide
Zinc
Dibutyldithiocarbamat
e (ZDBC)
Zinc
Diethyldithiocarbamate
(ZDEC).
Phenolic Antioxidant
Titanium Dioxide
Blue Pigment |
| Color | - | Blue | Blue |
| Texture | - | Finger textured | Finger textured |
| Size | Medical Glove
Guidance Manual -
Labeling | Small
Medium
Large
Extra Large | Extra Small
Small
Medium
Large
Extra Large |
| Single Use | Medical Glove
Guidance Manual -
Labeling | Single use | Single use |
| Manufacturer(s) | - | Advance Medical
Products Sdn Bhd | Advanced Healthcare
Products Sdn Bhd |
2
ﻢ ﺍﻟﻤﺴﻬ
AHP 510K Summary K132354 Page 3 of 5
3
7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data
The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above (ASTM Requirements).
8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
4
9.0 Conclusion
The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device.
Powder Free Blue Nitrile Patient Examination Glove, Non-Sterile will perform according to the gloves performance standards such as ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, the device is substantially equivalent to currently marketed devices.
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the department's name encircling a stylized symbol. The symbol resembles an abstract bird or eagle in flight, composed of three curved lines. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 30, 2014
Advanced Healthcare Products Sdn Bhd Mr. Francis V Operations Manager Lot 60 & 61, Lorong Senawang 3/2 Senawang Industrial Estate 70450 Seremban, Negeri Sembilan Darul Khusus, MALAYSIA
Re: K132354
·
Trade/Device Name: Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: May 20, 2014 Received: May 22, 2014
Dear Mr. Francis V:
We have reviewed your Section 510(k) promarket 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 docs 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.
6
Page 2 - Mr. Francis V
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-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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDeyices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 Purofitt-Sheth, M.D. Cliaical 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
7
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Indications for Use
510(k) Number (if known) K 132354
Device Name
Powder Free Blue Nitrile Patient Examination Glove Non-Sterile
Indications for Use (Describe)
A 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
0 Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Sreekanth Gutala
.. ::
.
Digitally signed by Sreekanth Gutala -5 DN; coUS, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=2000540490, cn=Sreekanth Gutala -5 Date: 2014,06.23 13:54:11 -04Y00'
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