(63 days)
Not Found
Not Found
No
The device is a standard examination glove and the summary provides no indication of AI/ML technology.
No
The device is described as an examination glove intended to prevent contamination, not to treat or cure a disease or condition.
No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, not to diagnose a medical condition.
No
The device description and performance studies clearly indicate the device is a physical product (examination gloves) and not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body.
- Device's Intended Use: The intended use of this device is to be worn on the examiner's hand or fingers to prevent contamination between the patient and the examiner. This is a barrier device used on the body (the examiner's hand).
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, chemical reactions, or diagnostic information derived from samples. The performance data focuses on the physical properties and barrier function of the glove.
Therefore, based on the provided information, this device is a medical device, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's for the expected contamination between patient and examiner. This device is for over-the counter use.
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. This device is for over-the counter use.
Product codes
LZA
Device Description
Non Sterile Powder Free Nitrile Examination Gloves meets all the current specifications listed under the ASTM Specification D6319-05, Standard Specification for Nitrile 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 or fingers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner; over-the-counter use
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
Performance data of gloves based on ASTM D6319-05 and FDA 1000ML watertight test.
Test results:
- Watertight (1000ml): Multiple Normal, GI AQL = 2.5, Pass
- Length (mm), Size M, L, XL: Min 230, 240 - 248
- Palm width (mm), Size M: 95 ± 10, 95 - 98
- Thickness (mm) (Single Layer) Finger: Min 0.05, 0.08 - 0.09
- Thickness (mm) (Single Layer) Palm: Min 0.05, 0.06 - 0.07
- Before Aging Tensile Strength (MPa): Min 14, 22-32
- Before Aging Ultimate Elongation (%): Min 500, 710-750
- After Aging Tensile Strength (MPa): Min 14, 22-29
- After Aging Ultimate Elongation (%): Min 400, 630-690
- Powder Content: Max 2.0mg/glove, Below 2 mg/glove
- Moisture Content: Max 2.0%, 0.57%
The performance data meet the ASTM D6319-05 Standard and FDA's requirement. Powder content is below 2 mg per glove which meet the FDA Requirements.
The Bio-compatibility Test consists of Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test. The gloves pass the Bio-compatibility Test.
Key Metrics
Not Found
Predicate Device(s)
Not Found
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.
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Ki0016.2
BIOGREEN YIELDS SDN. BHD. Lot 1422, Batu 10 Lekir 32020 SITIAWAN, PERAK, MALAYSIA
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・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
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MAR 2 4 2010
510(k) SUMMARY
1
BIOGREEN YIELDS SON. BHD. LOT 1422, BATU 10 LEKIR 32020 SITIAWAN, PERAK, MALAYSIA
| 510 (K) SUMMARY SHEETS |
|---|
| ------------------------ |
| 1.0 | |
|---|---|
| ----- | -- |
| SMDA 510 (K) SUMMARY | |
|---|---|
| 2.0 Submitter | BIOGREEN YIELDS SDN. BHD., |
| Lot 1422, Batu 10 Lekir | |
| • 32020 Sitiawan, Perak | |
| Malaysia | |
| Tel | 605-6792288 |
| Fax | 605-6791188 |
| Name of Contact Person | 1. Mr. Tiong Chiong Kieng |
- Mr. Arivalagan |
| Date of Summary Prepared | January 5, 2010 |
3.0 Name of Device
Trade Name: Non-Sterile, Blue Color Powder Free Nitrile Examination Glove
Common Name: Synthetic Rubber Examination Gloves
Classification Name: Patient Examination Glove, Powder Free
4.0 Identification of The Legally Marketed Devices
Non Sterile Powder Free Nitrile Examination Gloves as described in this 510k Notification is substantially equivalent to the current Class I patient examination glove bearing the product Specification DC310 06, School Specifications listed under the prove Specification D6319-05, Standard Specification for Nitrile Gloves for Medical Application.
5.0 Description of The Device
Non Sterile Powder Free Nitrile Examination Gloves meets all the current specifications listed under the ASTM Specification D6319-05, Standard Specification for Nitrile Examination Gloves for Medical Application.
2
BIOGREEN YIELDS SDN. BHD. Lot 1422, Batu 10 Lekir
32020 SITIAWAN, PERAK, MALAYSIA
6.0 The Intended Use of Glove
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's for the expected contamination between patient and examiner. This device is for over-the counter use.
7.0 Summary of Performance Data:
Performance data of gloves based on ASTM D6319-05 and FDA 1000ML watertight test.
| Test | FDA 1000ml Water Leak
Test | Powder Free Nitrile Examination
Gloves |
|-------------------------------------------------------------------|-------------------------------|-------------------------------------------|
| | Multiple Normal | |
| 1. Watertight (1000ml) | GI
AQL = 2.5 | Pass |
| Test | ASTM D6319-05 | |
| 2. Length (mm)
Size
M
L
XL | Min 230
Min 230 | 240 - 248 |
| 3. Palm width (mm)
Size
M | 95 ± 10 | 95 - 98 |
| 4. Thickness (mm)
(Single Layer) | | |
| Finger
Palm | Min 0.05
Min 0.05 | 0.08 - 0.09
0.06 - 0.07 |
| 5. Physical Properties | | |
| Before Aging
Tensile Strength (MPa)
Ultimate Elongation (%) | Min 14
Min 500 | 22 - 32
710 - 750 |
| After Aging
Tensile Strength (MPa)
Ultimate Elongation (%) | Min 14
Min 400 | 22 - 29
630 - 690 |
| 6. Powder Content | Max 2.0mg/glove | Below 2 mg/glove |
| 7. Moisture Content | Max 2.0% | 0.57% |
3
BIOGREEN YTELDS SDN. BHD. LOT 1422, BATU 10 LEKIR 32020 SITIAWAN, PERAK, MALAYSIA
- 8.0 The performance data of the glove as shown above meet the ASTM D6319-05 Standard and FDA's requirement. Powder content is below 2 mg per glove which meet the FDA Requirements.
- 9.0 The Bio-compatibility Test consists of Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test. The gloves pass the Bio-compatibility Test.
- 10.0 Conclusion
We conclude that the Non-Sterile, Blue Color Powder Free Nitrile Examination Gloves meets:
- . ASTM D6319-05 Standard
- . FDA pinhole requirements
- Are below the maximum Powder Residual Content as specified in ASTM D6319-05
4
Image /page/4/Picture/1 description: The image contains the logo for the U.S. Department of Health and Human Services. The logo features a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an eagle or bird in flight, rendered in blue. The overall design is clean and professional, representing the department's role in public health and welfare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 20 2010
Mr. Tiong Chiong Kieng Director Biogreen Yields Sdn. Bhd Lot 1422 Batu 10 Lekir Sitiawan Perak MALAYSIA 32020
Re: K100162
Trade/Device Name: Non Sterile, Blue Color Powder Free Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: January 5, 2010 Received: January 20, 2010
Dear Mr. Kieng:
This letter corrects our substantially equivalent letter of March 24, 2010 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 (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.
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.
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Page 2- Mr. Kieng
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Rusner
Anthony Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K100162
Device Name: Non Sterile, Blue Color Powder Free Nitrile Examination Gloves
Indications For Use:
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. This device is for over-the counter use.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ 1 (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
Page 1 of
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _ |