(131 days)
Not Found
No
The device is a medical examination glove, and the summary describes standard performance testing for such devices, with no mention of AI or ML.
No
This device is described as an examination glove intended to prevent contamination between healthcare personnel and patients, which is a barrier function, not a therapeutic one. It does not treat or cure any medical condition.
No
Explanation: The device is described as an "examination glove" used to "prevent contamination." Its function is protective, and there is no mention of it being used to diagnose conditions or processes.
No
The device is a physical glove made of nitrile, not a software application. The description focuses on material properties and physical performance testing.
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 gloves are "worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient." This describes a barrier device used for protection, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description focuses on the physical properties and standards met by the gloves (ASTM Specification D6319-10), which are relevant to their function as a protective barrier.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information. The device's function is purely physical protection.
IVD devices are used to perform tests on samples (like blood, urine, tissue) to diagnose diseases or conditions. This device does not perform any such tests.
N/A
Intended Use / Indications for Use
The Chlorinated Powder Free Nitrile Examination Gloves (Black Colour) is a single use disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
Product codes
LZA
Device Description
The Chlorinated Powder Free Nitrile Examination Gloves (Black Colour) meets all the Nitrile requirements of ASTM Specification D6319-10 Standard Specification for Examination Gloves for Medical Application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare and similar 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)
Not Found
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
K123116
Chlorinated Powder Free Nitrile Examination Gloves (Black Colour)
Attachment 15
510(k) SUMMARY
FEB 1 1 2013
Submitter : 1.0
| Name | : | Worldmed Manufacturing Sdn. Bhd. |
|---|---|---|
| Address | : | Lot 18873, Jalan Perusahaan 3, |
| Kamunting Industrial Estate, | ||
| 34600 Taiping, Perak, | ||
| Malaysia. | ||
| Phone No. | : | 605-892 5555 |
| Fax No . | : | 605-829 5590 |
| Contact Person | : | Ooi Loon Seng (Madam) |
September 5, 2012 Date of Preparation :
2.0 Name of the Device
Chlorinated Powder Free Nitrile Examination Gloves (Black Colour)
| Common Name | : Patient Examination Gloves |
|---|---|
| ------------- | ------------------------------ |
| Classification Name : | Patient Examination Gloves (CLASS I - 21CFR 880.6250) |
|---|---|
| ----------------------- | ------------------------------------------------------- |
510(K) Number
Identification of The Legally Marketed Devices That equivalency is claimed: 3.0
Primary Predicate:
RS BLACK Black Nitrile Medical Examination Gloves (Powder Free) Company : Riverstone Resources Sdn. Bhd. 510(K) : K112924
Additional Predicate:
Non-Sterile, Powder-Free, Black Nitrile Examination Glove Company : YTY Industry (Manjung) Sdn. Bhd. 510(K) : K061553
Description of the Device: 4.0
The Chlorinated Powder Free Nitrile Examination Gloves (Black Colour) meets all the Nitrile requirements of ASTM Specification D6319-10 Standard Specification for Examination Gloves for Medical Application.
5.0 Intended Use of the Device
The Chlorinated Powder Free Nitrile Examination Gloves (Black Colour) is a single use disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
1
Summary of the Technological Characteristics of the Device: 6.0
The Chlorinated Powder Free Nitrile Examination Gloves (Black Colour) are summarized with the following technological characteristics compared to ASTM Specification D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D6319-10 | Meets standard requirements |
| Physical Properties | ASTM D6319-10 | Meets standard requirements |
| Thickness | ASTM D6319-10 | Meets standard requirements |
| Biocompatibility | ISO 10993-10:2002/Amd | |
| 1:2006(E) Biological | ||
| evaluation of medical | ||
| devices - Part 10: Tests for | ||
| irritation and delayed-type | ||
| hypersensitivity |
Amendment 1:2006-07-15
ISO 10993-10:2002/Amd
1:2006(E) Biological
evaluation of medical
devices - Part 10: Tests for
irritation and delayed-type
hypersensitivity
Amendment 1:2006-07-15 | Pass (Not a primary skin
irritant)
Pass (Not a contact sensitizer) |
| Watertight (1000ml) | 21 CFR 800.20 | Pass |
7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data
The performance test data of non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above.
Substantial Equivalent Based on Assessment of Clinical Performance Data 8.0
Clinical data is not needed for gloves or most devices cleared by the 510(k) process.
2
Attachment 15
9.0 Substantial Equivalence Comparison
.
| Characteristic
and
parameters | Worldmed
Manufacturing
Sdn. Bhd. | Riverstone
Resources Sdn.
Bhd.
K112924 | YTY Industry
(Manjung) Sdn.
Bhd.
K061553 | Substantial
Equivalence
(SE) |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Product Code | LZA | LZA | LZA | |
| Intended use | The Chlorinated
Powder Free Nitrile
Examination
Gloves (Black
Colour) is a single
use device
intended for
medical purposes
that is worn on the
hand of healthcare
and similar to
personnel prevent
contamination
between the
healthcare
personnel and the
patient. | RS BLACK Black
Nitrile Medical
Examination
Gloves Powder
Free (Non-Sterile)
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. The
device is for over-
the-counter use. | The Non-Sterile,
Powder-Free, Black
Nitrile Examination
Glove is a disposable
device intended for
medical purpose that
is worn on the
examiner's hand or
finger to prevent
contamination
between patient and
examiner. | SE |
| Width
(Size Large) | Meets ASTM D
6319-10 (mm)
XS - 70 ± 10
S - 80 ± 10
M - 95 ± 10
L - 110 ± 10
XL-120 ± 10 | Meets ASTM D
6319-10 | Palm Width (mm)
Size XS: 73-78
S : 83-88
M : 93-98
L : 103-107 | SE |
| Overall length | Length ≥ 240mm | Meets ASTM D
6319-10 | 240mm minimum for
all sizes | SE |
| Palm thickness | Min 0.05mm | Meets ASTM D
6319-10 | Min 0.08 | SE |
| Finger
thickness | Min 0.05mm | Meets ASTM D
6319-10 | Min 0.08 | |
| Tensile
Strength before
aging min. | 14.0 MPa | Meets ASTM D
6319-10 | 15-21 MPa | |
| Tensile
Strength
after
aging min | 14.0 MPa | Meets ASTM D
6319-10 | 14-22 MPa | |
| Ultimate
elongation
before
aging
min | 500% | Meets ASTM D
6319-10 | 550 % - 630 % | |
| Ultimate
elongation after
aging | 400% | Meets ASTM D
6319-10 | 520 % - 610 % | |
| Meets
Biocompatibility | Yes | Yes | Yes | SE |
| Skin irritation | Passes | Passes | Passes | |
| Dermal
sensitization | Passes | Passes | Passes | |
| Residual
powder test | Passes - Below
2mg/glove | Meets ASTM D
6319-10 | Below 2 mg/glove | |
| Freedom from
Holes | Meets
Requirements per
21CFR800.20:
Gloves Free of
Holes at quality
level of AQL 1.5
(AQL 2.5 required
per standard) | Meets ASTM D
6319-10 | Multiple Normal GII
AQL=2.5 | Yes, SE |
| Materials | Nitrile Latex | Nitrile Latex
compound | - | Yes,
Substantial
Equivalence |
.
3
Chlorinated Powder Free Nitrile Examination Gloves (Black Colour)
Attachment 15
10.0 Conclusion
Chlorinated Powder Free Nitrile Examination Gloves (Black Colour) will perform according to the gloves performance standards referenced in section 6.0 above and meets ASTM standards and FDA requirements for water leak test on pinhole AQL. Consequently, the device is substantially equivalent to currently marketed devices.
4
Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered in the image. The words are stacked on top of each other.
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a stylized symbol that resembles a person embracing another person, or a symbol representing care and support. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 11, 2013
Ms. Ooi Loon Seng Regulatory Affairs Manager Worldmed Manufacturing Sdn. Bhd. Lot 18873, Jalan Perusahaan 3, Kamunting Industrial Estate Kamunting Perak, Malaysia 34600
Re: K123116
Trade/Device Name: Chlorinated Powder Free Nitrile Examination Gloves (Black Colour) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: 1 Product Code: LZA Dated: September 24, 2012 Received: November 13, 2012
Dear Ms. Seng:
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.
5
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
hoi
heth
Harshit.D.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Chlorinated Powder Free Nitrile Examination Gloves (Black Colour)
:
:
Attachment 2
INDICATIONS FOR USE
Applicant
WORLDMED MANUFACTURING SDN. BHD. Lot 18873, Jalan Perusahaan 3, Kamunting Industrial Estate, 34600 Taiping, Perak, Malaysia.
510(k) Number (if known)
Device Name
CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR)
Indications For Use
Chlorinated Powder Free Nitrile Examination Gloves (Black Colour) is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
Concurrence of CDRH Office of Device Evaluation (ODE )
| Prescription Use
| Per 21 CFR 801.109 | OR Over-The-Counter | X | ||
|---|---|---|---|---|
| Elizabeth F. Claverie | ||||
| 2013.02.11 13:32:02-05'00' | ||||
| (Division Sign-Off) | ||||
| Division of Anesthesiology, General Hospital | ||||
| Infection Control, Dental Devices | ||||
| 510(k) Number: | K123116 | Page 1 of 1 |