510k
Database
Specialties
Anesthesiology
540
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1663
Chemistry
362
Dental
1334
Ear, Nose, Throat
244
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963
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2184
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2043
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126
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97
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8
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466
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963
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433
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274
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2875
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52
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515
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2430
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155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
383
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Thai Rubber Gloves Co., Ltd.
Medical Device Manufacturer
·
TH , Nongyai
Thai Rubber Gloves Co., Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2021
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Thai Rubber Gloves Co., Ltd.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 20, 2022
Goody Gloves, Wincare, TBG Gloves
K213075
·
LZA
General Hospital
·
119d
Cleared
Dec 29, 2021
Goody Gloves, Wincare, TBG Gloves
K213073
·
LYY
General Hospital
·
97d
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General Hospital
2