510k
Database
Specialties
Anesthesiology
547
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1714
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380
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1356
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252
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982
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2217
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2087
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126
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100
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8
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474
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980
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441
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283
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3042
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52
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515
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2492
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155
Categories
LZA
Polymer Patient Examination Glove
416
LLZ
System, Image Processing,...
401
GEX
Powered Laser Surgical Instrument
363
FXX
Mask, Surgical
359
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Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
304
HRS
Plate, Fixation, Bone
295
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
232
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S&S Glove Corporation
Medical Device Manufacturer
·
VN , Ba Ria-Vung Tau
S&S Glove Corporation - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2023
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - S&S Glove Corporation
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 11, 2023
Powder Free White, Black, and Purple Nitrile Examination Glove
K231439
·
LZA
General Hospital
·
86d
Cleared
Feb 06, 2023
Powder Free Blue Nitrile Examination Glove
K223444
·
LZA
General Hospital
·
84d
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2
General Hospital
2