(81 days)
79 KGO
Not Found
No
The device description and performance studies focus on the physical properties and sterility of surgical gloves, with no mention of AI or ML.
No
The device, a surgeon's glove, is intended for barrier protection to prevent contamination, not to treat, cure, mitigate, or prevent disease or affect the structure/function of the body.
No
The device is described as a "surgeon's glove," which is a protective barrier worn during surgery, not a tool for diagnosing medical conditions.
No
The device description clearly states it is a physical product (Latex Surgeon's Gloves) and does not mention any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn on a surgeon's hands during surgical operations to prevent contamination. This is a physical barrier function, not a diagnostic test performed on samples from the body.
- Device Description: It's a physical glove.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
- Performance Data: The performance data focuses on physical properties like pinhole requirements, sterility, and meeting ASTM standards, which are relevant to a physical barrier device, not a diagnostic one.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This surgeon's glove does not fit that description.
N/A
Intended Use / Indications for Use
A surgeon's glove is a disposable device intended for medical purpose that is worn on surgeon's hands during surgical operations to prevent contamination between patient surgeon's.
A latex surgeon's glove is a disposable device intended for medical purpose that is worn on surgeon's hand during surgical operation to prevent contamination between patient and surgeon.
Product codes
79 KGO
Device Description
Not Found
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
Not Found
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)
- (7) Performance data is the same as mentioned immediately above.
- (8) Clinical date is not needed for gloves or for most devices cleared by the 510 (K) process.
- (9) Non-clinical data
We certify that the gloves meet or exceed the ASTM D 3577Standard Meets FDA pin hole requirement. Meets labeling claim. Meets the sterility assurance level.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Class I Surgeon's Gloves 79 KGO meeting ASTM D 3577 - Sterilized by gamma radiation
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the date November 5, 1999. The month is abbreviated to NOV. The day is the number 5. The year is 1999.
Image /page/0/Picture/2 description: The image shows a close-up of the word "Ma" written in a stylized, cursive font. The letters are bold and black, contrasting with the white background. Horizontal lines run across the top portion of the image, creating a textured effect behind the letters. A black border is visible at the bottom and left side of the image, framing the word.
PT. MAJA AGUNG LATEXINDO MANUFACTURING OF LATEX GLOVES
Jin. Utama No. 98 PUJI MULIO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA Telp. 62-61 - 859160 62-61 - 859170 Fax. 62-61 - 859180
Page Numbers 1 of 2
"510 (K)" SUMMARY
| (1) Name of applicant
Address | : Mr. Hansen Laurence
: PT. MAJA AGUNG LATEXINDO
Jl. H. Yamin No. 40 - 40 A
Medan 20234
Indonesia
Phone No. : 62-61-328888 ; 62-61-859170
Fax No. : 62-61-520588 ; 62-61-520588 |
|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The contact persons within the firm as well as in U.S.A are given below: | |
| Contact person in firm | : Mr. Hansen Laurence
Fax No. : 62-61-520588 : 62-61-859180 |
| Contact person in U.S.A | : Emmy Tjoeng
Fax No. : 626-913-1498 |
| (2) Device details
Trade Name | : Latex Surgeon's Gloves Pre-Powdered
Sterile |
| Classification Name | : Latex Surgeon's Gloves Pre-Powdered
Sterile |
| (3) Product Code | : 79 KGO |
| (4) Equivalent device legally
marketed | : Class I Surgeon's Gloves 79 KGO
meeting ASTM D 3577 - Sterilized
by gamma radiation |
| (5) Intended use | : A surgeon's glove is a disposable device intended for
medical purpose that is worn on surgeon's hands during
surgical operations to prevent contamination between
patient surgeon's |
1
Image /page/1/Picture/1 description: The image shows a stylized logo with the letters "Ma" in a cursive font. The letters are black and stand out against a background of horizontal lines. The left side of the logo has a thick black vertical bar, and the bottom of the logo has a thick black horizontal bar.
PT. MAJA AGUNG LATEXINDO
MANUFACTURING OF LATEX GLOVES
Telp. 62-61 - 859160 62-61 - 859170 Fax. 62-61 - 859180
Jln. Utama No. 98 PUJI MULIO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA
| a. Dimensions
| Sizes | 6½ | 7 | 7½ | 8 | 8½ |
|---|---|---|---|---|---|
| Length mm (min.) | 265 | 265 | 265 | 265 | 265 |
| PalmWidth mm | $83\pm6$ | $89\pm6$ | $95\pm6$ | $102\pm6$ | $108\pm6$ |
| Thickness |
- Cuff mm (min) | 0.10 | 0.10 | 0.10 | 0.1 | 0.1 |
| 2. Palm mm(min) | 0.10 | 0.10 | 0.10 | 0.1 | 0.1 |
| 3. Finger Tip mm | 0.10 | 0.10 | 0.10 | 0.1 | 0.1 |
b. Physical Properties
| | Before ageing | After ageing
at 70°C 168 hrs |
|----------------------------|----------------|---------------------------------|
| Tensile Strength | : 24 Mpa (min) | 18 Mpa (min) |
| Ultimate Elongation | : 750 % (min.) | 560 % (min.) |
| Stress at 500 % Elongation | : 5.5 (max) | : |
c. Performance Requirement
| Characteristic | Related Defects | Inspection
Level | AQL |
|---------------------|-----------------------------|---------------------|----------------|
| Watertight | Holes | S-4 | 1.5 |
| Dimensions | Width Length
& Thickness | S-2 | 4.0 |
| Physical Properties | Before and
after ageing | S-2 | 4.0 |
| Sterility | Fails sterility | | Not Acceptable |
- (7) Performance data is the same as mentioned immediately above.
- (8) Clinical date is not needed for gloves or for most devices cleared by the 510 (K) process.
- (9) Non-clinical data
We certify that the gloves meet or exceed the ASTM D 3577Standard Meets FDA pin hole requirement. Meets labeling claim. Meets the sterility assurance level.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MUN - 5 1999
PT. Maja Aqunq Latexindo c/o Ms. Emmy Tjoeng Official Correspondent for PT. Maja Aqunq Latexindo Shamrock Marketing Company, Incorporated 889 South Azusa Avenue City of Industry, California 91748
Re : K992752 Trade Name: Pre-Powdered Sterile Latex Surgeon's Gloves Requlatory Class: I Product Code: KGO Auqust 11, 1999 Dated: Received: August 16, 1999
Dear Ms. Tjoeng:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the qeneral controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
3
Page 2 - Ms. Tjoenq
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Clutrust
thy A. Ulatowski Diredtor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the digits '992752'. The digits are written in a simple, slightly irregular style, typical of handwriting.
Image /page/4/Picture/1 description: The image shows a close-up of the letters 'Ma' in a stylized font. The letters are black and are set against a background of horizontal lines. The letters are bold and have a rounded appearance.
MAJA AGUNG LATEXIN
MANUFACTURING OF LATEX GLOVE
Jln. Utama No. 98 PUJI MULIO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA Telp. 62-61 - 859160 62-61 - 859170 Fax. 62-61 - 859180
ANNEXURE II
INDICATION FOR USE
| Applicant | : Mr. Hansen Laurence |
|---|---|
| Device Name | : Latex Surgeon's Gloves Pre-Powdered |
| Sterile | |
| Indication for use | : |
A latex surgeon's glove is a disposable device intended for medical purpose that is worn on surgeon's hand during surgical operation to prevent contamination between patient and surgeon.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) | |
| Division Sign-Off | |
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | K992752 |
| Over-The-Counter Use | X |
| (Optional Format 1-2-96) |